FDA Tentatively OKs Dr. Reddy’s Generic Lenacapavir — SkimNews
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- FDA tentatively approved Dr. Reddy’s to make generic lenacapavir, a key step toward widening access in dozens of low- and middle-income countries.
- Dr. Reddy’s is one of the world’s largest generic drugmakers and plans to start shipping the medicine next month, following an access effort propelled in part by several global health organizations.
- Generic lenacapavir is planned at an annual cost of $40 per person, comparable to the cost of daily tablets.
- Lenacapavir is widely seen as offering virtually complete protection against contracting HIV with one administration every six months.
- Gilead Sciences markets the brand-name version, Yetzugo, which received FDA approval last year.
Why it matters: People in dozens of low- and middle-income countries are the intended beneficiaries: the generic’s stated annual cost is $40 per person, and Dr. Reddy’s plans to ship next month. That advances access to a twice-yearly injectable HIV prevention option, while the brand-name product received FDA approval last year.
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