FDA panel recommends approval for experimental Gilead HIV drug
FOSTER CITY, Calif. — Gilead Sciences scored a second favorable Food and Drug Administration expert panel vote as the FDA's Antiviral Drugs Advisory Committee recommended on Friday that the regulatory agency approve an experimental drug designed to treat HIV.
Gilead announced that the FDA panel voted 13-1 to support approval of the Quad (elvitegravir, cobicistat, emtricitabine and tenofovir disoproxil fumarate) for HIV-1 infection in adults that have not received previous treatments. The FDA isn't required to follow advisory committee votes when deciding whether to approve a drug, but usually does.
The treatment is designed as a once-daily regimen that combines four HIV drugs in one pill. The FDA's recommendation is based on results of two phase-3 clinical trials indicating that the Quad demonstrated non-inferiority to Gilead's Atripla (efavirenz, emtricitabine and tenofovir disoproxil fumarate) and a regimen containing Truvada (tenofovir disoproxil fumarate) and Bristol-Myers Squibb's Reyataz (atazanavir) boosted with Abbott's Norvir (ritonavir).
The news closely follows the advisory committee's recommendation that the FDA approve Gilead's Truvada for pre-exposure prophylaxis, or PrEP, in which HIV-negative patients take the drug daily to reduce their risk of infection.