FDA Approves Second Gilead Drug For Daily PrEP

October 3, 2019 Medicine, Science

Gilead Sciences, the drug giant behind the blockbuster HIV prevention pill Truvada, won FDA approval on Thursday to market Descovy — a medication already used by those who have HIV — as its next-generation prevention drug.

The final approval follows an August vote in favor of Descovy as a pre-exposure prophylaxis medication, or PrEP, by an FDA advisory panel. Descovy is now approved for HIV PrEP in everyone except people who have vaginal sex, since its efficacy has not been studied in this population; for these patients, Truvada is an approved option.

This year, Gilead announced that a generic version of Truvada would hit the market in September 2020, and the company also promised to donate 2.4 million bottles annually of its most up-to-date HIV PrEP medication — which as of Thursday is Descovy — for President Donald Trump’s proposed Ending the HIV Epidemic plan.

BREAKING: FDA approves Gilead’s next-generation HIV PrEP pill, Descovy https://t.co/VIhNWiMzz8

— NBC Out (@NBCOUT) October 3, 2019

Today FDA approved the second drug to prevent HIV infection as part of ongoing efforts to end the HIV epidemic. https://t.co/rwTMwZyLPL #endHIVepidemic pic.twitter.com/4ihHmoBkA9

— U.S. FDA (@US_FDA) October 3, 2019

#AIDS activists argue there is no reason why HHS should not pursue royalties on Descovy, currently approved for treating #HIV. https://t.co/llO3fTR4mJ

— STAT (@statnews) July 2, 2019