via Washingtonpost.com, by Brian Vastag
The Food and Drug Administration is delaying by three months a decision on whether to approve a drug for preventing infection with HIV, the virus that causes AIDS.
An agency decision on the drug Truvada, made by Gilead Sciences, was expected by June 15. But the decision was pushed back to give the agency time to review a new Gilead plan to limit the risks to healthy people taking the drug, Cara Miller, a company spokeswoman, said Friday.
If approved, Truvada would become the first drug marketed for prevention of HIV. The FDA will now make a decision by Sept. 14.
In May, a committee of FDA advisers recommended that the agency approve Truvada for HIV prevention in specific high-risk groups, including men who have sex with men and partners of those infected with HIV.
After that meeting, the FDA asked Gilead to revise its risk-management plan for the drug, Miller said.
She declined to provide details on how Gilead revised this plan, which is known as a risk evaluation and management strategy.
During the May meeting, FDA advisers wrestled with safety concerns, including fears that men taking the drug would see it as an excuse to stop using condoms, and worries that healthy people would not take the drug daily as prescribed.
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[Content that is linked from other sources is for informational purposes and should not construe a Mapping Pathways position. Please look for us on Facebook here www.facebook.com/MappingPathways and you can follow us on Twitter @mappingpathways as well.]
The Food and Drug Administration is delaying by three months a decision on whether to approve a drug for preventing infection with HIV, the virus that causes AIDS.An agency decision on the drug Truvada, made by Gilead Sciences, was expected by June 15. But the decision was pushed back to give the agency time to review a new Gilead plan to limit the risks to healthy people taking the drug, Cara Miller, a company spokeswoman, said Friday.
If approved, Truvada would become the first drug marketed for prevention of HIV. The FDA will now make a decision by Sept. 14.
In May, a committee of FDA advisers recommended that the agency approve Truvada for HIV prevention in specific high-risk groups, including men who have sex with men and partners of those infected with HIV.
After that meeting, the FDA asked Gilead to revise its risk-management plan for the drug, Miller said.
She declined to provide details on how Gilead revised this plan, which is known as a risk evaluation and management strategy.
During the May meeting, FDA advisers wrestled with safety concerns, including fears that men taking the drug would see it as an excuse to stop using condoms, and worries that healthy people would not take the drug daily as prescribed.
Read the rest.
[Content that is linked from other sources is for informational purposes and should not construe a Mapping Pathways position. Please look for us on Facebook here www.facebook.com/MappingPathways and you can follow us on Twitter @mappingpathways as well.]
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