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Gilead's Descovy May Have Problem Getting HIV Prevention Indication In Cisgender Women

 
• By Sue Sutter

Descovy demonstrated noninferiority to Truvada in men and transgender women who have sex with men, but pharmacokinetic data do not support a demonstration of pre-exposure prophylaxis efficacy in cisgender women, US FDA says in advisory committee briefing document.

Aids red ribbon on woman's hand support for World aids day and national HIV/AIDS and aging awareness month concept - Image
Gilead is seeking to expand the labeling of Descovy to include HIV pre-exposure prophylaxsis. • Source: Shutterstock

The US Food and Drug Administration is asking its Antimicrobial Drugs Advisory Committee whether Gilead Sciences Inc. has more work to do before Descovy (emtricitabine/tenofovir alafenamide) can be approved for use as HIV pre-exposure prophylaxis in cisgender women.

In briefing document released ahead of a 7 August meeting, the agency suggests Gilead’s pharmacokinetic data are insufficient to...

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US FDA’s June Approval Forecast: Infection Prevention, Cancer And HAE

 
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AMR-Targeting Drug Secures EMA PRIME Designation

 
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Keep Talking: US FDA’s Beleaguered Biologics Center Remains Vital To Regenerative Medicine

 
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This is an update of recommendations from the European Medicines Agency's Committee for Medicinal Products for Human Use on the authorization of new medicines in the EU, and updates on EU marketing authorization changes recommended by the CHMP.