STAT+: FDA OKs generic HIV prevention shot, widening access for lower-income countries — SkimNews
Get the Health newsletter
Daily health & science — research, biotech, public health, the studies worth knowing. Free.
- FDA granted tentative approval to Dr. Reddy's to make a generic version of lenacapavir, a key step toward widening access in dozens of low- and middle-income countries.
- Dr. Reddy's, one of the world's largest generic drugmakers, plans to start shipping the medicine next month, an effort propelled in part by several global health organizations pressing for availability in lower-income countries as quickly as possible.
- Lenacapavir is widely seen as a game-changing tool for eradicating HIV, offering virtually complete protection against contracting the virus with a single administration every six months.
- The generic version is set to cost $40 per person per year, comparable to the annual cost of daily prevention tablets.
- Gilead Sciences markets the brand-name version, known as Yetzugo in the U.S., which the FDA approved last year.
Why it matters: The beneficiaries are health programs and people in dozens of low- and middle-income countries who have not had access to Gilead's brand-name injectable: at $40 per person per year, the generic matches the annual cost of daily pills while offering the same twice-yearly dosing. Approval changes what those programs can procure, not what the U.S. brand offers.
Ask SkimNews
