Gilead Sciences, the drug giant behind the blockbuster HIV prevention pill Truvada, won FDA approval on Thursday to market Descovy — a medication already used by those who have HIV — as its next-generation prevention drug.
The final approval follows an August vote in favor of Descovy as a pre-exposure prophylaxis medication, or PrEP, by an FDA advisory panel.
Descovy is not yet approved for certain groups, including women who have vaginal sex, since its efficacy has not been studied in this population; for these patients, Truvada is an approved option.
“Descovy for PrEP provides a new HIV prevention option that matches Truvada’s high efficacy with statistically significant improvements in renal and bone safety, which can be an important consideration as people at risk increasingly use PrEP for longer periods of time,” Daniel O’Day, Gilead’s CEO, said in a statement.
Like Truvada, Descovy is taken once daily and can reduce the transmission of HIV by over 95 percent. According to GoodRx, a one month’s supply of Descovy and Truvada both retail for roughly $1,800, though few U.S. patients pay this price as PrEP is covered by private and public insurance.
This year, Gilead announced that a generic version of Truvada would hit the market in September 2020, and the company also promised to donate 2.4 million bottles annually of its most up-to-date HIV PrEP medication — which as of Thursday is Descovy — for President Donald Trump’s proposed Ending the HIV Epidemic plan.
Gilead has long been buffeted by HIV activists like the PrEP4All coalition over the high price of Truvada and the circumstances of Truvada’s development and testing, which was largely funded by private donors and the U.S. government. That information was first publicized by the Global Health Justice Partnership at Yale University, which wrote "based on our preliminary review, CDC’s Patents for PrEP appear to be valid and enforceable."