First Generic Injectable HIV Prevention Drug Wins FDA Tentative Approval: Twice-Yearly Shots at $40 a Year
Indian drugmaker Dr. Reddy's Laboratories and its global health partners, including Unitaid, announced on November 2 that the U.S. Food and Drug Administration (FDA) has granted tentative approval to the company's generic injectable lenacapavir. It is the first generic long-acting injectable for HIV prevention to clear this step, removing a key regulatory barrier to supplying a twice-yearly prevention shot at $40 per person per year across 120 low- and middle-income countries.
The generic is intended for adults and adolescents weighing at least 35 kilograms, as pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1, and was reviewed through the FDA's President's Emergency Plan for AIDS Relief (PEPFAR) program. The originator drug is Yeztugo, made by U.S. company Gilead Sciences, which the FDA approved for HIV prevention in June 2025; it was nearly 100% effective in large trials and costs about $28,000 a year in the United States. Dr. Reddy's is the first of six manufacturers licensed by Gilead to receive tentative approval.
Tentative approval means the product has met all of the FDA's standards for safety, effectiveness and quality, but cannot yet be sold in the United States because the originator's patent and exclusivity protections remain in force; the approval instead supports procurement and market entry in low- and middle-income countries. The $40 annual price was agreed in September 2025 with Unitaid, the Clinton Health Access Initiative and the Wits Reproductive Health and HIV Institute at South Africa's University of the Witwatersrand, putting it roughly in line with the annual cost of daily oral PrEP.
Under the partners' timeline, initial supplies are expected to reach the first countries before the end of 2026, with broader availability across eligible countries in 2027. Deepak Sapra, Dr. Reddy's chief executive for API and services, said in the release: "The U.S. FDA approval validates that work and brings us a significant step closer to making this twice-yearly HIV prevention option available to people across low- and middle-income countries."
(Source: U.S. Food and Drug Administration)
Source: U.S. Food and Drug Administration
Published by GSM · USA (original Chinese edition)
Photo: lenacapavir（来那卡帕韦）分子结构图（Dzinamarira 等作，CC BY 4.0，经 Wikimedia Commons）
