Gilead’s Marketing Of Descovy For HIV Prevention Should Not Suggest Superiority To Truvada
US FDA advisory committee members urge agency to hold a firm line against labeling, promotional or educational materials that suggest Descovy has better efficacy or is safer than Truvada, which will face generic competition in 2020. Panel backs HIV pre-exposure prophylaxis indication for Descovy but recommends excluding cisgender women due to lack of clinical efficacy data.
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The latest drug development news and highlights from our US FDA Performance Tracker.
US FDA approves a PrEP indication for emtricitabine/tenofovir alafenamide that excludes cisgender women due to a lack of efficacy evidence; Gilead will conduct a new randomized trial with a novel design in women comparing Descovy's efficacy and safety against external controls and Truvada.
US FDA's advisory committee review of Gilead’s Descovy for pre-exposure prophylaxis of HIV wasn’t exactly free of controversy. But the meeting sure went more smoothly than the first PrEP review seven years ago.