A next-generation HIV drug from Gilead Sciences Inc., which could be more effective and have fewer side effects with a lower dosage, will go to federal regulators for a decision on whether it should be approved.
The drug — a combination of Gilead's emtricitabine and tenofovir alafenamide, or TAF — is the second so-called F/TAF drug submitted by the Foster City-based company (NASDAQ: GILD) to the Food and Drug Administration.
In November, it filed for approval of a once-daily, single-tablet regiment containing elvitegravir, cobicistat, emtricitabine and TAF, and a decision on that drug is expected by Nov. 5.
. Gilead's F/TAF could unleash a fresh round of HIV drug combos, says Chief Scientific Officer Norbert Bischofberger. This latest new drug application, or NDA, filing seeks approval of two doses of F/TAF for adults and children age 12 and older in combination with other HIV antiretroviral drugs.
The filing is backed by a late-stage trial that indicated that F/TAF could fight off the AIDS virus at a dose less than one-tenth that of Gilead's Viread, which features an earlier version of tenofovir at 300 milligrams.
The study, with HIV patients who hadn't received antiretroviral drugs previously, pitted F/TAF against Stribild, which includes that earlier version of tenofovir, and found that F/TAF was at least equal in efficacy to Stribild and had fewer kidney and bone side effects than Stribild.
Other trials tested F/TAF in adult HIV patients who switched drug regimens, treatment-naive adolescents and adults with mild-to-moderate kidney impairment.
The earlier version of tenofovir also is used in Gilead's other HIV-fighting combination drugs — Truvada, Atripla, Complera and Stribild — so F/TAF could serve as the centerpiece for a whole new set of drug combos.
By Ron Leuty
San Francisco Business Times
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