Dr. Reddy’s Wins Tentative FDA Approval for Lenacapavir

On 2 November 2026, Dr. Reddy’s Laboratories received tentative approval from the U.S. Food and Drug Administration (FDA) for a generic, twice-yearly injectable form of lenacapavir for HIV prevention. The approval was granted under the President’s Emergency Plan for AIDS Relief (PEPFAR).

Eligibility, access and next steps

The long-acting injection is intended for pre-exposure prophylaxis (PrEP), to reduce the risk of sexually acquired HIV-1 among adults and adolescents weighing at least 35 kg. First supplies are expected to reach eligible countries by December 2026, followed by a broader rollout in 2027.

Under an agreement involving Dr. Reddy’s, Unitaid, the Wits Reproductive Health and HIV Institute and the Clinton Health Access Initiative, the product is to be offered for $40 per person per year in 120 countries covered by Gilead Sciences’ voluntary licence. Gilead granted Dr. Reddy’s the licence in October 2024; the four organisations entered the access and development agreement in September 2025. The company said WHO prequalification and national regulatory approvals remain among the steps towards wider availability.

CHAI chief executive Neil Buddy Shah said the generic’s tentative approval came 16 months after the originator product, showing what access-focused development could achieve.

Important Facts for Exams

• Capsid binding: Lenacapavir binds between HIV-1 p24 capsid-protein subunits in capsid hexamers, disrupting essential stages of viral replication.
• Drug class: Lenacapavir was the first capsid inhibitor approved by the FDA for treating HIV/AIDS.
• Treatment and prevention uses: For multidrug-resistant HIV treatment, lenacapavir (Sunlenca) is combined with other antiretrovirals; Yeztugo and Yeytuo are used for PrEP.