The panel voted against recommending the prevention pill for use in cisgender women due to inadequate data on efficacy in this patient population.
An FDA panel has backed Gilead’s HIV prevention drug Descovy (emtricitabine/ tenofovir alafenamide). The Antimicrobial Drug Advisory Committee last week recommended approval for the pre-exposure prophylaxis (PrEP) pill for men and transgender women who have sex with men.
However, the panel voted against recommending the prevention pill for use in cis-gender women due to inadequate data on efficacy in this patient population.
“We appreciate the advisory committee’s thoughtful review and discussion of the data during today’s meeting and look forward to collaborating with the FDA to make this potential new prevention option available to people at risk of HIV in the United States,” Diana Brainard, MD, senior vice president, HIV and Emerging Viruses, Gilead, said in a statement. “If approved for a PrEP indication, Descovy could play a meaningful role in the federal initiative to address the nation’s epidemic.”
If Descovy is approved for HIV prevention by the FDA, this will be Gilead’s second HIV prevention pill on the market. Currently, Gilead’s Truvada (emtricitabine/tenofovir disoproxil fumarate) is the only FDA-approved treatment for PrEP. Descovy was approved in April 2016 for the treatment of HIV.
The FDA panel assessed data from the DISCOVER global phase 3 study, which compared the safety and efficacy of Descovy with Truvada in men and transgender women who have sex with men and are at a high risk of sexually acquired HIV. Results showed that Descovy was noninferior to Truvada.
The trial also revealed statistically significant improvements in renal and bone measures for those taking Descovy. This finding mirrors other data indicating that tenofovir alfenamide and tenofovir alfenamide­—containing products produce a lower risk of bone and kidney toxicities than tenofovir disoproxil fumarate equivalents.
The most common side effect of the pill was nausea, which occurred in 10% of patients.
In May, Gilead vowed to donate PrEP for up to 200,000 people for up to 11 years and said that it would donate Truvada until Descovy was approved. Stakeholders have also said that approval of Descovy would send a message to managed care plans that often don’t currently cover Truvada because they are only aware of its use as an HIV treatment. The pill costs $1675 a month, or approximately $20,000 a year, so without coverage, many are forced to forgo taking the pill.