FDA delays approval of Gilead HIV drugs

Drug maker receives complete response letter for elvitegravir, cobicistat for use in HIV treatment regimens

FOSTER CITY, Calif. — The Food and Drug Administration declined to approve two drugs for HIV made by Gilead Sciences for which the company was seeking approval for use as part of treatment regimens.

The drug maker said it received complete response letters from the FDA for elvitegravir and cobicistat; the FDA said it could not approve the regulatory applications for the drug in their current forms due to deficiencies in documentation and validation of some quality-testing procedures and methods found during recent inspections. The company said it was working to address the problems cited in the letters.

The FDA issues a complete response letter when it has finished reviewing an application, but problems found preclude the application's approval in its present form.

Elvitegravir and cobicistat are components of Gilead's single-tablet HIV drug Stribild (elvitegravir 150 mg; cobicistat 150 mg; emtricitabine 200 mg; tenofovir disoproxil fumarate 300 mg). The company said the FDA's decision would not affect its authorization to market Stribild.

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