Gilead scores PrEP approval for Descovy — kicking off marketing push before Truvada generics swarm
The FDA has cleared Gilead’s Descovy — a top pipeline drug it spent a priority review voucher on — for HIV pre-exposure prophylaxis in a broad, but not all-encompassing, population.
Regulators have excluded from the PrEP label anyone at-risk for HIV from receptive vaginal sex. The decision fell in line with both internal reviews and outside expert opinions at the FDA, which concluded that while Descovy showed efficacy for men and transgender women who have sex with men, the data weren’t sufficient to justify giving the drug to cisgender women, a group that makes up a small portion of the overall PrEP group.
Nonetheless, CEO Daniel O’Day clearly felt the occasion momentous enough to warrant a shout out directly from the top, noting:
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.
Selling that pitch to payers, after all, will be key to realizing the $3.8 billion peak sales that Geoff Porges of SVB Leerink has estimated for the drug. Truvada generics are set to hit the market in 2020, and patients advocates have openly questioned how commonly Descovy should be prescribed against the older, cheaper PrEP.
“Based on the science that we have seen thus far, there is no indication that everyone needs to be taking Descovy,” Tim Horn, director of medication access and pricing at the National Alliance of State and Territorial AIDS Directors, previously told Reuters.
Descovy, which earned $700 million for Gilead in the first half of this year, shares the same emtricitabine component with Truvada, but swaps out TAF, or tenofovir alafenamide, for TDF (tenofovir disoproxil fumarate).
Gilead has attracted considerable criticism regarding Truvada from US politicians, who highlighted that the pill costs $8 per month in some parts of Australia versus $1,780 in its home country.
Just before a congressional hearing in May the drugmaker committed to donating up to 2.4 billion bottles of Truvada to the CDC for uninsured Americans at risk for HIV until 2030 — playing its part in the government’s stated goal of ending the epidemic — and noted it would transition to Descovy once it’s approved for PrEP.