FDA Clears Affordable Generic HIV Prevention Shot

American drug regulators have given tentative approval to a generic form of lenacapavir, a twice-yearly injection used to prevent HIV. The announcement was made on November 2 by the drug’s manufacturer and organizations involved in its development. The approval could help speed access in 120 low- and middle-income countries.

India-based Dr. Reddy’s Laboratories developed the generic through a partnership arranged by Wits RHI alongside Unitaid and the Clinton Health Access Initiative. The expected price is $40 per person a year, matching the cost of some daily prevention pills. The injections are needed far less often, and two major studies found they nearly eliminated new infections among people at high risk.

Generic lenacapavir will not be available for sale in the United States while Gilead Sciences’ brand-name version, Yeztugo, remains protected by a patent. Its U.S. list price is $28,218 a year. Gilead has entered into no-cost royalty licenses with six generic drugmakers for production in designated countries.

The FDA’s tentative approval is part of a process intended to ensure the quality of HIV-related medicines supplied abroad with U.S. government support. The generic may become available in some countries within weeks, though national approval procedures could delay access elsewhere. Other manufacturers’ generic versions have not yet received FDA approval.

Users need an HIV test before starting lenacapavir and before each injection. Side effects can include injection-site reactions, headache and nausea; use by someone with an undiagnosed HIV infection can be associated with drug-resistant HIV. Advocates say funding and delivery systems will be needed to get the drug to the millions of people who could benefit.