Gilead gains FDA backing for new HIV combo pill Genvoya

The US Food and Drug Administration yesterday approved US biotech giant Gilead Sciences’ (Nasdaq: GILD) Genvoya (a fixed-dose combination tablet containing elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide) as a complete regimen for the treatment of HIV-1 infection in adults and pediatric patients 12 years of age and older.

Genvoya, essentially a safer alternative to Gilead’s Truvada (emtricitabine and tenofovir), is the first TAF-based regimen to receive FDA approval. The therapy recently received a positive opinion form the Committee for Medicinal Products for Human Use (CHMP), the scientific committee of the European Medicines Agency (The Pharma Letter September 26). Market reaction to the news was slightly negative, with the stock falling 1.06% to $107.83 by close of trading yesterday.

Annual treatment cost $31,362