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Descovy, Truvada And The Politics Of PrEP

Executive Summary

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.

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Gilead, US FDA Ponder Innovative Designs For Descovy HIV Prevention Study In Women

Advisory committee sent a clear message that pre-exposure prophylaxis studies are needed in cisgender women, but what those studies might look like, and whether the agency can exercise its statutory authorities to ensure they are conducted, is less clear.

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.

Gilead's Descovy HIV Prevention Indication Should Exclude Women, US FDA Advisory Cmte. Says

Gilead and the FDA failed women by letting PrEP application get this far without clinical efficacy data in non-transgendered females, panel members say in close vote against a broad indication; panelists urge the agency to mandate such studies regardless of the breadth of the HIV pre-exposure prophylaxis indication ultimately granted to the Truvada successor.

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