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.

Unlock this article instantly by becoming a free subscriber.

You’ll get access to free articles each month, plus you can customize what newsletters get delivered to your inbox each week, including breaking news.

SIGN UP LOG IN BECOME A PREMIUM SUBSCRIBER