Thursday, February 28, 2013
Special program increases birth control use in at-risk teens
(Reuters) - Long after completing an 18-month program designed to teach them about contraception and healthy relationships, U.S. teens at high risk for pregnancy were still using contraceptives more often, among other safe sexual practices, a U.S. study said.
The teen pregnancy rate in the United States is the highest in the developed world, researchers writing in JAMA Pediatrics said. According to the U.S. Centers for Disease Control and Prevention, in 2011 31 out of every 1,000 U.S. teenage girls between the ages of 15 and 19 gave birth to a baby.
But researchers in Minnesota developed and tested an approach to teen pregnancies based on providing access to birth control methods and information as well as building the girls' sense of connectedness to family and society.
'Our study shows that when we invest in young people through ongoing one-on-one relationships, through opportunities to lead and access to sex and health services, we really support the next generation of citizens,' said Renee Sieving, the study's lead author from the University of Minnesota in Minneapolis.
For the study, Sieving's team recruited 253 sexually active girls between 13 and 17 years old from clinics in St. Paul and Minneapolis, to be randomly placed in one of two groups.
All would get standard care at the clinic, but half would also be enrolled in the researchers' youth development program.
At the study's outset, just over half of all the girls in both groups, around 56 percent, were using condoms on more than half of the occasions that they had sex. More than 40 percent said they used condoms less than half of the time.
Just 2 percent of girls in each group were also on some other type of birth control, such as the Pill.
One group of 127 girls did not receive any special attention, other than the clinic's standard care and guidance. The other 126 girls were assigned to the new program.
Each girl in the program got a case manager who taught about healthy relationships, contraceptive use and how to become more involved with school and family. Those teens also went through training to educate others about what they were learning.
Six months after the 18-month program ended, the teens were asked about their sexual behavior.
Girls who did not go through the program ended up using a condom during sex less consistently than they had two years earlier. But the girls who went through the program did 50 percent better at using a condom every time they had sex than they had when the study began.
The use of other contraceptives increased in both groups, but especially the group that went through the special program.
Those girls were also more likely to say they were close with their family, and were more confident in turning down unwanted sex. In addition, they were also more likely to go to college or technical school, Sieving said.
'The kids we're working with are oftentimes struggling in school - the kid in the back of the room you don't often hear from, and we give them tools,' Sieving said.
'You watch them move from 'I don't really have anything that's of any use to anybody,' to 'Wow, I have stuff to contribute! So it's really cool to see that shift in how they see themselves.' SOURCE: http://bit.ly/V9WKBO
(Reporting from New York by Andrew Seaman at Reuters Health; editing by Elaine Lies)
The teen pregnancy rate in the United States is the highest in the developed world, researchers writing in JAMA Pediatrics said. According to the U.S. Centers for Disease Control and Prevention, in 2011 31 out of every 1,000 U.S. teenage girls between the ages of 15 and 19 gave birth to a baby.
But researchers in Minnesota developed and tested an approach to teen pregnancies based on providing access to birth control methods and information as well as building the girls' sense of connectedness to family and society.
'Our study shows that when we invest in young people through ongoing one-on-one relationships, through opportunities to lead and access to sex and health services, we really support the next generation of citizens,' said Renee Sieving, the study's lead author from the University of Minnesota in Minneapolis.
For the study, Sieving's team recruited 253 sexually active girls between 13 and 17 years old from clinics in St. Paul and Minneapolis, to be randomly placed in one of two groups.
All would get standard care at the clinic, but half would also be enrolled in the researchers' youth development program.
At the study's outset, just over half of all the girls in both groups, around 56 percent, were using condoms on more than half of the occasions that they had sex. More than 40 percent said they used condoms less than half of the time.
Just 2 percent of girls in each group were also on some other type of birth control, such as the Pill.
One group of 127 girls did not receive any special attention, other than the clinic's standard care and guidance. The other 126 girls were assigned to the new program.
Each girl in the program got a case manager who taught about healthy relationships, contraceptive use and how to become more involved with school and family. Those teens also went through training to educate others about what they were learning.
Six months after the 18-month program ended, the teens were asked about their sexual behavior.
Girls who did not go through the program ended up using a condom during sex less consistently than they had two years earlier. But the girls who went through the program did 50 percent better at using a condom every time they had sex than they had when the study began.
The use of other contraceptives increased in both groups, but especially the group that went through the special program.
Those girls were also more likely to say they were close with their family, and were more confident in turning down unwanted sex. In addition, they were also more likely to go to college or technical school, Sieving said.
'The kids we're working with are oftentimes struggling in school - the kid in the back of the room you don't often hear from, and we give them tools,' Sieving said.
'You watch them move from 'I don't really have anything that's of any use to anybody,' to 'Wow, I have stuff to contribute! So it's really cool to see that shift in how they see themselves.' SOURCE: http://bit.ly/V9WKBO
(Reporting from New York by Andrew Seaman at Reuters Health; editing by Elaine Lies)
Wednesday, February 27, 2013
Program increases contraceptive use in at-risk teens
NEW YORK (Reuters Health) - Long after completing an 18-month program designed to teach about contraception and healthy relationships, teenage girls at high risk for unwanted pregnancy were using contraceptives more often and maintaining other safer sexual practices, according to a new study.
Researchers in Minnesota tested an approach to preventing teen pregnancies that is based on providing access to birth control methods and information as well as building girls' sense of connectedness to family and society.
'Our study shows that when we invest in young people through ongoing one-on-one relationships, through opportunities to lead and access to sex and health services, we really support the next generation of citizens,' said Renee Sieving, the study's lead author from the University of Minnesota in Minneapolis.
According to the U.S. Centers for Disease Control and Prevention, 31 out of every 1,000 teenage girls between 15 and 19 years old gave birth to a baby in 2011.
That is a record low, but still the highest teen pregnancy rate in the developed world, Sieving and her colleagues point out in the journal JAMA Pediatrics. They add that black and Hispanic teens bear most of the burden of these teen pregnancies.
For the new study, Sieving's team recruited 253 sexually active girls between 13 and 17 years old from clinics in St. Paul and Minneapolis, to be randomly placed in one of two groups.
All would get standard care at the clinic, but half would also be enrolled in the researchers' 'Prime Time' youth development program.
At the study's outset, just over half of all the girls in both groups (around 56 percent) were using condoms on more than half of the occasions that they had sex. More than 40 percent said they used condoms less than half of the time.
Just 2 percent of girls in each group were also on some other type of birth control, such as the Pill.
One group of 127 girls did not receive any special attention - other than the clinic's standard care and guidance. The other 126 girls were assigned to the new program.
Prime Time assigned each girl participating in that program a case manager who taught about healthy relationships, contraceptive use and how to become more involved with school and family.
The Prime Time teens also went through training to become leaders and teachers who could educate others about what they were learning.
The program took 18 months to complete, and the teens were then asked about their behaviors six months after it the program's end.
The researchers found that the girls who did not go through the program ended up using a condom during sex less consistently than they had two years earlier.
Girls who went through the program, however, ended up doing about 50 percent better at using a condom every time they had sex than at the beginning of the study.
The use of other contraceptives also increased in both groups, but more in the group who went through the Prime Time program.
The girls who went through the program were also more likely to say they were close with their family, and were more confident in turning down unwanted sex. In addition, the Prime Time teens were also more likely to go to college or technical school, according to Sieving.
'The kids we're working with are oftentimes struggling in school - the kid in the back of the room you don't often hear from, and we give them tools,' Sieving said.
'You watch them move from 'I don't really have anything that's of any use to anybody,' to 'Wow, I have stuff to contribute!' So it's really cool to see that shift in how they see in themselves,' she added.
Amy Bleakley, who studies teen sexual behavior and reproductive health at the University of Pennsylvania in Philadelphia, said the results are promising.
'I think that investment in youth development programs such as this could yield positive results for high-risk adolescent girls,' said Bleakley, who was not involved with the new study.
Sieving told Reuters Health that compared to the approximately $10.9 billion teen pregnancy cost U.S. taxpayers in 2008, investing in this type of program also makes financial sense. The Prime Time program costs about $2,800 per teen, she said.
'I just think when you invest in ways that help kids to thrive, it's good for our next generation and there is some cost saving involved,' she added.
SOURCE: http://bit.ly/V9WKBO JAMA Pediatrics, online February 26, 2012.
Researchers in Minnesota tested an approach to preventing teen pregnancies that is based on providing access to birth control methods and information as well as building girls' sense of connectedness to family and society.
'Our study shows that when we invest in young people through ongoing one-on-one relationships, through opportunities to lead and access to sex and health services, we really support the next generation of citizens,' said Renee Sieving, the study's lead author from the University of Minnesota in Minneapolis.
According to the U.S. Centers for Disease Control and Prevention, 31 out of every 1,000 teenage girls between 15 and 19 years old gave birth to a baby in 2011.
That is a record low, but still the highest teen pregnancy rate in the developed world, Sieving and her colleagues point out in the journal JAMA Pediatrics. They add that black and Hispanic teens bear most of the burden of these teen pregnancies.
For the new study, Sieving's team recruited 253 sexually active girls between 13 and 17 years old from clinics in St. Paul and Minneapolis, to be randomly placed in one of two groups.
All would get standard care at the clinic, but half would also be enrolled in the researchers' 'Prime Time' youth development program.
At the study's outset, just over half of all the girls in both groups (around 56 percent) were using condoms on more than half of the occasions that they had sex. More than 40 percent said they used condoms less than half of the time.
Just 2 percent of girls in each group were also on some other type of birth control, such as the Pill.
One group of 127 girls did not receive any special attention - other than the clinic's standard care and guidance. The other 126 girls were assigned to the new program.
Prime Time assigned each girl participating in that program a case manager who taught about healthy relationships, contraceptive use and how to become more involved with school and family.
The Prime Time teens also went through training to become leaders and teachers who could educate others about what they were learning.
The program took 18 months to complete, and the teens were then asked about their behaviors six months after it the program's end.
The researchers found that the girls who did not go through the program ended up using a condom during sex less consistently than they had two years earlier.
Girls who went through the program, however, ended up doing about 50 percent better at using a condom every time they had sex than at the beginning of the study.
The use of other contraceptives also increased in both groups, but more in the group who went through the Prime Time program.
The girls who went through the program were also more likely to say they were close with their family, and were more confident in turning down unwanted sex. In addition, the Prime Time teens were also more likely to go to college or technical school, according to Sieving.
'The kids we're working with are oftentimes struggling in school - the kid in the back of the room you don't often hear from, and we give them tools,' Sieving said.
'You watch them move from 'I don't really have anything that's of any use to anybody,' to 'Wow, I have stuff to contribute!' So it's really cool to see that shift in how they see in themselves,' she added.
Amy Bleakley, who studies teen sexual behavior and reproductive health at the University of Pennsylvania in Philadelphia, said the results are promising.
'I think that investment in youth development programs such as this could yield positive results for high-risk adolescent girls,' said Bleakley, who was not involved with the new study.
Sieving told Reuters Health that compared to the approximately $10.9 billion teen pregnancy cost U.S. taxpayers in 2008, investing in this type of program also makes financial sense. The Prime Time program costs about $2,800 per teen, she said.
'I just think when you invest in ways that help kids to thrive, it's good for our next generation and there is some cost saving involved,' she added.
SOURCE: http://bit.ly/V9WKBO JAMA Pediatrics, online February 26, 2012.
GlaxoSmithKline unit joins patent pool for AIDS drugs
LONDON (Reuters) - GlaxoSmithKline's HIV/AIDS drugs business is to share intellectual property rights on children's medicine in a patent pool designed to make treatments more widely available in poor countries.
ViiV Healthcare, majority-owned by GSK, is the second research-based pharmaceutical business to sign up to the new Medicines Patent Pool, following a lead set in 2011 by Gilead Sciences.
Although more than half of people living with the human immunodeficiency virus (HIV) that causes AIDS now get the drugs they need - thanks to a major roll-out of treatment in Africa - an estimated 6.8 million still go without, according to UNAIDS.
The Medicines Patent Pool (MPP), launched in 2010 by the UNITAID health financing system that is funded by a levy on airline tickets, aims to address the remaining gap by getting patent holders to share know-how with makers of cheap generic drugs.
In the case of ViiV, a key pediatric medicine known as abacavir will be made available to generic manufacturers which will be able to take a license to make and sell it in 118 poor countries, the patent pool said on Wednesday.
ViiV and the patent pool have also agreed to negotiate further licenses that will allow generics firms to manufacture low-cost versions of an experimental drug, dolutegravir, that is currently awaiting regulatory approval in Western markets.
There are 3.4 million children living with HIV worldwide but only 562,000 have access to medicines. Treating them is challenging because many drugs are not adapted for use in children.
Abacavir and dolutegravir are both seen as priority products for fighting HIV in poor countries. ViiV also sells other older drugs, some of which are already off patent and available as cheaper generics.
ViiV - which is owned 76.5 percent by GSK, 13.5 percent by Pfizer and 10 percent by Shionogi - only signed up to the patent pool after lengthy negotiations.
Some other major drugmakers have yet to join.
Bristol-Myers Squibb, Roche and privately owned Boehringer-Ingelheim are currently discussing plans to join the scheme, but Abbott, Johnson & Johnson and Merck have so far remained outside.
J&J decided in November to take unilateral action by not enforcing its patents on HIV drug Prezista in a limited number of poor countries, in a move that disappointed campaigners who argued joining the pool would have been more effective.
(Reporting by Ben Hirschler, Editing by Kate Kelland and Mark Potter)
ViiV Healthcare, majority-owned by GSK, is the second research-based pharmaceutical business to sign up to the new Medicines Patent Pool, following a lead set in 2011 by Gilead Sciences.
Although more than half of people living with the human immunodeficiency virus (HIV) that causes AIDS now get the drugs they need - thanks to a major roll-out of treatment in Africa - an estimated 6.8 million still go without, according to UNAIDS.
The Medicines Patent Pool (MPP), launched in 2010 by the UNITAID health financing system that is funded by a levy on airline tickets, aims to address the remaining gap by getting patent holders to share know-how with makers of cheap generic drugs.
In the case of ViiV, a key pediatric medicine known as abacavir will be made available to generic manufacturers which will be able to take a license to make and sell it in 118 poor countries, the patent pool said on Wednesday.
ViiV and the patent pool have also agreed to negotiate further licenses that will allow generics firms to manufacture low-cost versions of an experimental drug, dolutegravir, that is currently awaiting regulatory approval in Western markets.
There are 3.4 million children living with HIV worldwide but only 562,000 have access to medicines. Treating them is challenging because many drugs are not adapted for use in children.
Abacavir and dolutegravir are both seen as priority products for fighting HIV in poor countries. ViiV also sells other older drugs, some of which are already off patent and available as cheaper generics.
ViiV - which is owned 76.5 percent by GSK, 13.5 percent by Pfizer and 10 percent by Shionogi - only signed up to the patent pool after lengthy negotiations.
Some other major drugmakers have yet to join.
Bristol-Myers Squibb, Roche and privately owned Boehringer-Ingelheim are currently discussing plans to join the scheme, but Abbott, Johnson & Johnson and Merck have so far remained outside.
J&J decided in November to take unilateral action by not enforcing its patents on HIV drug Prezista in a limited number of poor countries, in a move that disappointed campaigners who argued joining the pool would have been more effective.
(Reporting by Ben Hirschler, Editing by Kate Kelland and Mark Potter)
Thursday, February 21, 2013
Most women misunderstand IUD birth control
NEW YORK (Reuters Health) - In a new survey, most women had inaccurate perceptions about the safety and effectiveness of intrauterine devices (IUDs) in preventing pregnancy, say U.S. researchers, who urge doctors to talk more about the benefits of the devices.
In particular, many of the study participants didn't know that IUDs are more effective contraceptives than the birth control pill and that the devices don't increase the risk of getting a sexually transmitted disease.
'It's not clear whether women have an overly optimistic view of the effectiveness of the birth control pill or an overly pessimistic view of the IUD,' said Dr. Lisa Callegari, the study's lead author and a clinical assistant professor at the University of Washington.
Whatever their source, these misperceptions lead to underuse of 'one of the most safe and effective methods' of birth control, said Dr. Jeffrey Peipert, an obstetrics and gynecology professor at Washington University, who was not part of the study.
IUDs, which include the brand name products ParaGard and Mirena, are small plastic or copper-and-plastic objects inserted into the uterus. They can be left implanted for years, and are more than 99 percent effective at preventing pregnancy.
In contrast, the birth control pill has been found in real-world practice to be about 95 percent effective.
Callegari said that earlier studies have highlighted some of the mistaken beliefs women have about IUDs, and she and her colleagues wanted to get a better sense of how common they are among average women visiting primary care clinics.
They surveyed more than 1,600 women between the ages of 18 and 50 who had visited one of four clinics in Pennsylvania.
Five percent of the women were currently using an IUD, and another 5.8 percent had used one previously.
Only about one in five of the women correctly stated that IUDs are more effective at preventing pregnancy than the Pill.
And just 28 percent knew that an IUD is more cost effective than the Pill when it is used for more than three years, the researchers report in the medical journal Contraception.
According to Planned Parenthood, the upfront costs of an IUD are between $500 and $1,000, whereas birth control pills can cost between $15 and $50 a month - so they become more expensive over time.
The women in the study were considerably more knowledgeable about the risk of disease related to an IUD, with 57 percent answering correctly that there is no greater risk of contracting a sexually transmitted disease with an IUD compared to the Pill.
Still, Peipert said he's not surprised that women might view IUDs less favorably.
'There's been a LOT of bad press about IUDs in the past,' Peipert wrote in an email to Reuters Health.
For instance, thousands of women have sued the makers of the Dalkon Shield, an IUD sold in the 1970s, because of injuries sustained from infections.
'It's not surprising, because of the history of the IUD in the United States, that people still have inaccurate perceptions of the device,' said Dr. Rebecca Allen, an assistant professor of obstetrics and gynecology at Brown University, who was not involved in the study.
Currently available devices are considered to be much safer, said Allen.
Indeed, women over age 36 tended to have more misperceptions than younger women who took the survey, the researchers note in their report.
It's likely, too, that many women are simply not as familiar with the devices as they are with the Pill, said Callegari.
According to a 2012 study by the Centers for Disease Control and Prevention (CDC), 28 percent of women of reproductive age use oral contraception, making the Pill the most common form of birth control, followed closely by sterilization methods like getting the fallopian tubes 'tied,' used by 27 percent of women.
The same CDC study found that IUD use had risen from 0.8 percent of reproductive-age women in 1995 to 5.6 percent in 2010.
To correct widespread misconceptions about IUDs, Allen said, health care providers should be encouraged to talk to their patients about the devices.
Among women who have never used an IUD, Callagari's study found that those who had been counseled about the device by a health care provider were more knowledgeable than women who hadn't discussed it.
'I think it helps to give more evidence that providers should be talking with patients about IUDs,' she told Reuters Health. 'Women hear it and it affects their perceptions.'
Providers themselves might need to be educated too, however.
One recent survey of physicians found that 30 percent had outdated ideas about IUDs, including thinking they are unsafe for women who had never had a baby or being unsure about their safety (see Reuters Health story of March 28, 2012 here: http://reut.rs/HhJ0dH).
'We need to educate more primary care providers about the facts about IUDs so that they can counsel their patients,' said Allen.
SOURCE: http://bit.ly/XP6lK8 Contraception, online February 18, 2013.
In particular, many of the study participants didn't know that IUDs are more effective contraceptives than the birth control pill and that the devices don't increase the risk of getting a sexually transmitted disease.
'It's not clear whether women have an overly optimistic view of the effectiveness of the birth control pill or an overly pessimistic view of the IUD,' said Dr. Lisa Callegari, the study's lead author and a clinical assistant professor at the University of Washington.
Whatever their source, these misperceptions lead to underuse of 'one of the most safe and effective methods' of birth control, said Dr. Jeffrey Peipert, an obstetrics and gynecology professor at Washington University, who was not part of the study.
IUDs, which include the brand name products ParaGard and Mirena, are small plastic or copper-and-plastic objects inserted into the uterus. They can be left implanted for years, and are more than 99 percent effective at preventing pregnancy.
In contrast, the birth control pill has been found in real-world practice to be about 95 percent effective.
Callegari said that earlier studies have highlighted some of the mistaken beliefs women have about IUDs, and she and her colleagues wanted to get a better sense of how common they are among average women visiting primary care clinics.
They surveyed more than 1,600 women between the ages of 18 and 50 who had visited one of four clinics in Pennsylvania.
Five percent of the women were currently using an IUD, and another 5.8 percent had used one previously.
Only about one in five of the women correctly stated that IUDs are more effective at preventing pregnancy than the Pill.
And just 28 percent knew that an IUD is more cost effective than the Pill when it is used for more than three years, the researchers report in the medical journal Contraception.
According to Planned Parenthood, the upfront costs of an IUD are between $500 and $1,000, whereas birth control pills can cost between $15 and $50 a month - so they become more expensive over time.
The women in the study were considerably more knowledgeable about the risk of disease related to an IUD, with 57 percent answering correctly that there is no greater risk of contracting a sexually transmitted disease with an IUD compared to the Pill.
Still, Peipert said he's not surprised that women might view IUDs less favorably.
'There's been a LOT of bad press about IUDs in the past,' Peipert wrote in an email to Reuters Health.
For instance, thousands of women have sued the makers of the Dalkon Shield, an IUD sold in the 1970s, because of injuries sustained from infections.
'It's not surprising, because of the history of the IUD in the United States, that people still have inaccurate perceptions of the device,' said Dr. Rebecca Allen, an assistant professor of obstetrics and gynecology at Brown University, who was not involved in the study.
Currently available devices are considered to be much safer, said Allen.
Indeed, women over age 36 tended to have more misperceptions than younger women who took the survey, the researchers note in their report.
It's likely, too, that many women are simply not as familiar with the devices as they are with the Pill, said Callegari.
According to a 2012 study by the Centers for Disease Control and Prevention (CDC), 28 percent of women of reproductive age use oral contraception, making the Pill the most common form of birth control, followed closely by sterilization methods like getting the fallopian tubes 'tied,' used by 27 percent of women.
The same CDC study found that IUD use had risen from 0.8 percent of reproductive-age women in 1995 to 5.6 percent in 2010.
To correct widespread misconceptions about IUDs, Allen said, health care providers should be encouraged to talk to their patients about the devices.
Among women who have never used an IUD, Callagari's study found that those who had been counseled about the device by a health care provider were more knowledgeable than women who hadn't discussed it.
'I think it helps to give more evidence that providers should be talking with patients about IUDs,' she told Reuters Health. 'Women hear it and it affects their perceptions.'
Providers themselves might need to be educated too, however.
One recent survey of physicians found that 30 percent had outdated ideas about IUDs, including thinking they are unsafe for women who had never had a baby or being unsure about their safety (see Reuters Health story of March 28, 2012 here: http://reut.rs/HhJ0dH).
'We need to educate more primary care providers about the facts about IUDs so that they can counsel their patients,' said Allen.
SOURCE: http://bit.ly/XP6lK8 Contraception, online February 18, 2013.
Wednesday, February 20, 2013
Gilead, Teva reach settlement in Viread patent lawsuit
(Reuters) - Gilead Sciences Inc said it has agreed with Israel's Teva Pharmaceuticals Industries Ltd to settle a lawsuit relating to patents protecting Viread, a treatment for HIV infection and chronic hepatitis B.
As per the agreement, Gilead said Teva will be allowed to launch a generic version of Viread on December 15, 2017.
'This settlement removes some uncertainty and minimizes further distraction and investment of human and financial resources associated with this litigation,' Gilead's chief operating officer, John Milligan, said in a statement late on Tuesday.
Gilead, based in California, is the world's largest maker of branded drugs to treat the human immunodeficiency virus, the cause of AIDS.
The trial in the lawsuit, which was scheduled to begin on February 20 in a Manhattan court, has been adjourned to finalize the settlement, Gilead said.
(Reporting by Sakthi Prasad in Bangalore; Editing by Matt Driskill)
This article is sponsored by real estate news.
As per the agreement, Gilead said Teva will be allowed to launch a generic version of Viread on December 15, 2017.
'This settlement removes some uncertainty and minimizes further distraction and investment of human and financial resources associated with this litigation,' Gilead's chief operating officer, John Milligan, said in a statement late on Tuesday.
Gilead, based in California, is the world's largest maker of branded drugs to treat the human immunodeficiency virus, the cause of AIDS.
The trial in the lawsuit, which was scheduled to begin on February 20 in a Manhattan court, has been adjourned to finalize the settlement, Gilead said.
(Reporting by Sakthi Prasad in Bangalore; Editing by Matt Driskill)
This article is sponsored by real estate news.
Monday, February 18, 2013
GSK wins priority status for new HIV drug in U.S
LONDON (Reuters) - U.S. regulators gave priority review status to an experimental GlaxoSmithKline drug for HIV/AIDS, which industry analysts view as a possible multibillion-dollar-a-year seller.
The U.S. Food and Drug Administration awards certain drugs priority status when they have the potential to offer significant improvement over existing treatments.
The agency is due to give its verdict on whether to approve dolutegravir by August 17, Britain's biggest drugmaker said on Friday.
The once-daily drug, which belongs to a novel class known as integrase inhibitors that block the virus causing AIDS from entering cells, is owned by ViiV Healthcare, a joint venture focused on HIV in which GSK is the largest shareholder.
The new medicine has already performed strongly in clinical trials, prompting GSK to raise its bet on the product last October by redrawing a deal with Japan's Shionogi.
Under that agreement Shionogi agreed to take a 10 percent stake in Viiv - which was set up in 2009 between GSK and Pfizer - in exchange for its shared rights to dolutegravir.
The agreement left GSK holding 76.5 percent of ViiV, with Pfizer controlling 13.5 percent and Shionogi the remainder.
Analysts see dolutegravir as a strong competitor to HIV treatments from market leader Gilead Sciences.
(Reporting by Ben Hirschler. Editing by Jane Merriman)
This article is sponsored by free dating site.
The U.S. Food and Drug Administration awards certain drugs priority status when they have the potential to offer significant improvement over existing treatments.
The agency is due to give its verdict on whether to approve dolutegravir by August 17, Britain's biggest drugmaker said on Friday.
The once-daily drug, which belongs to a novel class known as integrase inhibitors that block the virus causing AIDS from entering cells, is owned by ViiV Healthcare, a joint venture focused on HIV in which GSK is the largest shareholder.
The new medicine has already performed strongly in clinical trials, prompting GSK to raise its bet on the product last October by redrawing a deal with Japan's Shionogi.
Under that agreement Shionogi agreed to take a 10 percent stake in Viiv - which was set up in 2009 between GSK and Pfizer - in exchange for its shared rights to dolutegravir.
The agreement left GSK holding 76.5 percent of ViiV, with Pfizer controlling 13.5 percent and Shionogi the remainder.
Analysts see dolutegravir as a strong competitor to HIV treatments from market leader Gilead Sciences.
(Reporting by Ben Hirschler. Editing by Jane Merriman)
This article is sponsored by free dating site.
Subscribe to:
Posts (Atom)