STAT+: FDA OKs generic HIV prevention shot, widening access for lower-income countries

Ed’s stories explore prescription drug pricing, affordability and access, as well issues surrounding patents, litigation, and legislation. He is also the author of the morning Pharmalittle newsletter and the afternoon Pharmalot newsletter.

After months of anticipation, the Food and Drug Administration gave tentative approval to Dr. Reddy’s Laboratories to make a generic version of a groundbreaking HIV prevention medicine, a key step in widening access for dozens of low- and middle-income countries.

The company, one of the world’s largest generic drugmakers, plans to start shipping the medicine next month as part of an effort propelled, in part, by several global health organizations to ensure the drug becomes available in lower-income countries as quickly as possible. The annual cost per person will be $40, comparable to daily tablets.

Known as lenacapavir, the injectable drug is widely seen as a game-changing tool for eradicating HIV because it offers virtually complete protection against contracting the virus with just one administration every six months. The brand-name version, which is known as Yetzugo in the U.S., is marketed by Gilead Sciences and was approved by the FDA last year.