The FDA's approval of the second-ever HIV prevention drug Oct. 3 explicitly excluded women, which some activists and scientists argue sets a dangerous precedent, according to The New York Times.
The approval doesn't include women because Gilead only tested Descovy in men and transgender women. Additionally, the approval announcement made no mention of a plan to make it available to women.
Activists and scientists told The New York Times the intentional exclusion of women sets a dangerous precedent by allowing drugmakers to avoid paying for expensive trials to test medicine in women.
Excluding women in clinical drug trials "should be unacceptable in these days and times," Rochelle Walensky, MD, chief of infectious diseases at Boston-based Massachusetts General Hospital, told The New York Times.
FDA officials told The New York Times that although the approval announcement made no mention of testing the drug in women, the agency will require Gilead to study the effects of Descovy on women. The FDA will require the trial to be completed by December 2024, according to the report.
Gilead is considering conducting the trial in southern Africa by the end of 2020, studying at least 1,500 women at high-risk for HIV infection.
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