Dr. Reddy’s Laboratories has received tentative approval from the United States Food and Drug Administration for its injectable lenacapavir. This medication is used to reduce the risk of HIV-1. The approval was granted under the President’s Emergency Plan for AIDS Relief programme, providing a regulatory basis for the company to seek further international clearances.
The USFDA decision allows the company to pursue World Health Organization pre-qualification and additional national regulatory approvals. Under an existing agreement, the injectable will be available at $40 per person per year across 120 countries outside the United States. These nations are covered by a voluntary licence held by Gilead Sciences.
Dr. Reddy’s Laboratories expects the first supplies to reach these countries before the end of 2026. A broader rollout across the eligible nations is planned for 2027. Based in Hyderabad, Telangana, the company manufactures and markets a wide range of pharmaceutical products in India and overseas markets.
Based on company and agency reports. For information only; not investment advice.