Narrower Descovy label for PrEP unlikely to hamper Gilead

While FDA's approval of Gilead’s Descovy to reduce the risk of HIV-1 infection does not include the cisgender women population as expected, the narrower label is unlikely to significantly affect sales.

The agency approved Thursday Descovy emtricitabine/tenofovir as PrEP for men and transgender women who have sex with men, expanding its label beyond its 2015 approval to treat HIV-1 infection in adults and pediatric patients. The label expansion excludes cisgender women, which follows an August advisory committee vote of 10-8 recommending against the therapy in that population. A Phase III trial that supported Descovy's approval for PrEP did not include cisgender women. ...