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FDA Declines Approval of Elvitegravir and Cobicistat as Stand-alone HIV Meds

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The U.S. Food and Drug Administration (FDA) has rejected approval of Gilead Sciences' integrase inhibitor elvitegravir and pharmacoenhancer cobicistat -- components of the 4-in-1 Stribild quad pill -- as single agents for treatment of HIV, the company announced last week.

Gilead took the unusual step of requesting marketing approval of Stribild, which also contains tenofovir DF and emtricitabine (the drugs in Truvada), as a coformulated single-tablet regimen before all the individual components were approved. The company sought approval of elvitegravir and cobicistat in June 2012, shortly before the FDA approved the combo pill that August.

According to a recent Gilead press release, the FDA's Complete Response Letters stated that, "during recent inspections, deficiencies in documentation and validation of certain quality testing procedures and methods were observed." The company did not further detail the problems identified, but said it is "working with FDA to address the questions raised...and move the applications forward."

The FDA did not raise safety concerns about either elvitegravir or cobicistat, and the status of Stribild is not affected.

5/8/13

Source

Gilead Sciences. Gilead Receives Complete Response Letters from U.S. Food and Drug Administration for Elvitegravir and Cobicistat. Press release. April 29, 2013.