FDA Week - 08/09/2019

Gilead’s Proposed PrEP Drug Sparks Data Extrapolation, Cost Concerns

By Beth Wang
August 8, 2019 at 12:11 AM
Patient advocates and a panel of experts on Wednesday (Aug. 7) laid out a host of concerns with drug maker Gilead’s proposal to allow its already-approved HIV drug Descovy to be used for pre-exposure prophylaxis (PrEP). The two core issues: Gilead wants Descovy to be indicated for use in cisgender women based on extrapolated data because the company never conducted efficacy trials in cisgender women; and some patient advocates worry expanding Descovy into the PrEP space might allow Gilead to...

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