Dr. Reddy’s Laboratories secures lenacapavir approval
Key Highlights
Dr. Reddy’s Laboratories has received tentative USFDA approval for its injectable lenacapavir to help reduce HIV-1 risk in 120 countries.
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.