FDA Clears Generic Twice-Yearly HIV Prevention Shot for Overseas Use
The U.S. Food and Drug Administration has tentatively approved a generic version of lenacapavir, a twice-yearly injection that helps prevent HIV. The decision could accelerate access in 120 low- and middle-income countries, where the generic is expected to cost about $40 US per person annually.
Lenacapavir is a form of pre-exposure prophylaxis, or PrEP, for people at risk of HIV. Two studies involving people at high risk found that the injections nearly eliminated new infections. Unlike daily preventive pills, the shot is given twice a year. At the expected generic price, it would cost about the same as currently available daily pills.
India-based Dr. Reddy’s Laboratories developed the generic through an agreement supported by Unitaid, the Clinton Health Access Initiative and Wits RHI. The FDA’s tentative approval reflects the continued patent protection of Gilead Sciences’ brand-name product, Yeztugo. The generic cannot be sold in the United States while that patent remains in effect. Yeztugo’s U.S. list price is $28,218 annually before insurance.
FDA review can help speed approval in other countries, but access will not be immediate everywhere. Some governments require their own regulatory assessments. Partners involved in the effort say the generic could become available in some locations within weeks. Gilead has also granted royalty-free licences to six generic manufacturers for specified countries in Africa, Asia and Latin America; their versions have not yet received FDA approval.
The injection requires HIV testing before treatment begins and at each subsequent dose. Using it while an infection remains undiagnosed can lead to drug-resistant HIV. Reported side effects include reactions at the injection site, headaches and nausea.
Health organizations say wider use will depend on purchasing funds and distribution systems, not approval alone. They estimate that about 20 million people worldwide need PrEP. Generic supply may help meet that need, though the scale and timing of access remain uncertain.