Approval of India-made version of HIV-prevention shot raises hopes in low-income countries

The US Food and Drug Administration approved an India-made generic version of the world's only twice-a-year HIV prevention shot, known as lenacapavir. This significant development is expected to make the drug more affordable and accessible in 120 low- and middle-income countries. Dr. Reddy's Laboratories, an India-based company, developed the generic under an agreement facilitated by Unitaid, the Clinton Health Access Initiative, and Wits RHI, a health research institute in Africa.

The partners aimed to expedite development and make the drug available at a reasonable cost. The new drug is anticipated to cost USD 40 per year per person, similar to the daily preventive pill prices currently available. However, the shots offer greater convenience due to their infrequent administration and proven effectiveness in reducing new infections in high-risk individuals.

Despite the approval, the generic version cannot be sold in the U.S. due to the patent protection of the brand-name version, Yeztugo, manufactured by Gilead Sciences. Gilead Sciences, the sole supplier of lenacapavir, established royalty-free licensing agreements with six generic manufacturers to facilitate production in various countries.

The FDA's approval of the generic drug may facilitate regulatory approval in multiple countries, potentially accelerating access to this essential preventive medication.