US: F.D.A. Approves New H.I.V.-Prevention Drug, but Not for Cisgender Women

The Food and Drug Administration on Thursday approved a new drug, Descovy, for prevention of infection with H.I.V., only the second drug approved for this purpose.

The first, Truvada, has become a mainstay of government efforts to turn back the H.I.V. epidemic. But the F.D.A. approved Descovy for use only in men and transgender women, because its maker, Gilead Sciences, tested it only in those groups.

The approval explicitly excludes cisgender women, and does not outline a plan for making the drug available to them. Some activists and scientists said the approval sets a dangerous precedent by allowing companies to dodge the expensive trials needed to test medicines in cisgender women.

Such an exclusion “should be unacceptable in these days and times,” said Dr. Rochelle Walensky, chief of infectious diseases at Massachusetts General Hospital. Read more via New York Times