Gilead’s PrEP drug Descovy should be approved for men and transgender women but not cis-gender women, FDA advisory panel says

pharmafile | August 8, 2019 | News story | Research and Development AIDS, Gilead, HIV, PrEP, descovy, pharma 

Independent experts on a panel advising the FDA have voted in favour of Gilead’s new PrEP drug Descovy in men and transgender women who have sex with men.

However the panel voted against expanding Descovy’s label to cover the drug as a preventative treatment for cis-gendered women.

Descovy which is a combination of emtricitabine and tenofovir alafenamide, is currently approved as a treatment for chronic HIV.

California drugmaker Gilead are now seeking approval for the drug as a means of reducing the risk of contracting of HIV.

The panel voted 16-2 in favour of the drug as a pre-exposure prophylaxis (PrEP) of HIV in men and transgender women who have sex with men, a group who form the largest portion of the market for PrEP.

However the panel said there was not enough data to support the expansion of the Descovy’s label to cover cis-gendered women, voting 10-8 against the proposition.

The FDA is yet to make its final decision on Descovy. The agency does however often follow the advice of its advisory panels.

Louis Goss

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