Turn on cookies to sign in
Signing in saves your progress to your Curie account. We can only do that with cookies on — turn them on to continue.
The FDA has approved a generic version of lenacapavir, the world's only twice-yearly HIV prevention shot, paving the way for affordable access across 120 low- and middle-income countries. At just $40 per person annually — a fraction of the $28,000+ U.S. list price — the drug could reach the 20 million people globally who need PrEP. Experts say it could be a turning point in ending the HIV epidemic.
The FDA has granted tentative approval to a generic version of lenacapavir (brand name: Yeztugo), the world's only twice-yearly injectable HIV prevention drug, opening the door to affordable access in 120 low- and middle-income countries. Developed by India-based Dr. Reddy's Laboratories in partnership with Unitaid, the Clinton Health Access Initiative, and Wits RHI, the generic is expected to cost just $40 per person per year — matching the price of daily PrEP pills but with far greater convenience.
The approval is "tentative" under FDA rules, as the brand-name version from Gilead Sciences remains under patent in the U.S. (where it lists at $28,218/year). Still, FDA approval is expected to fast-track regulatory clearance in many other countries, with the drug potentially reaching some markets within weeks. Two landmark studies showed lenacapavir nearly eliminated new HIV infections in high-risk populations, making scale-up a compelling public health priority.
By the Numbers:
Why it matters: With a low-cost, high-quality generic now in the pipeline, global health advocates believe scaling access could meaningfully curb — and potentially end — the HIV epidemic in the world's most affected communities.
