Dr. Reddy's Laboratories has secured tentative approval for its injectable lenacapavir used for reducing HIV-1 risk from United States Food and Drug Administration (USFDA). The approval was granted under the USFDA’s President's Emergency Plan for AIDS Relief (PEPFAR) programme. The USFDA decision provides a regulatory basis for further steps, including World Health Organization (WHO) pre-qualification and national regulatory approvals.
Under an existing agreement, the injectable will be made available at $40 per person per year across 120 countries outside the US covered by Gilead Sciences' voluntary licence. The first supplies are expected to reach countries before the end of 2026, with a broader rollout across eligible nations planned in 2027.
Dr. Reddy's Laboratories is a multinational pharmaceutical company based in Hyderabad, Telangana in India. It manufactures and markets a wide range of pharmaceuticals in India and overseas.
