Gilead scores PrEP approval for Descovy — kicking off marketing push before Truvada generics swarm
The FDA has cleared Gilead’s Descovy — a top pipeline drug it spent a priority review voucher on — for HIV pre-exposure prophylaxis in a broad, but not all-encompassing, population.
Regulators have excluded from the PrEP label anyone at-risk for HIV from receptive vaginal sex. The decision fell in line with both internal reviews and outside expert opinions at the FDA, which concluded that while Descovy showed efficacy for men and transgender women who have sex with men, the data weren’t sufficient to justify giving the drug to cisgender women, a group that makes up a small portion of the overall PrEP group.
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