With US FDA approval of HIV prevention drug Lenacapavir, expert urges India to lead in ensuring fair and timely access

The U.S. Food and Drug Administration (FDA) has approved Lenacapavir, sold under the brand name Yeztugo, as a new long-acting injectable medication to prevent HIV. This landmark decision, made on June 18, 2025, introduces a biannual preventive option that could significantly change the way HIV is managed, especially for high-risk groups.

Lenacapavir is the first HIV prevention drug of its kind—a capsid inhibitor that only needs to be taken twice a year. Clinical trials have shown nearly 100% effectiveness in preventing HIV among men who have sex with men, transgender people, and cisgender women. This offers a major advantage over daily oral PrEP (pre-exposure prophylaxis), which many struggle to take consistently.

While the approval is being hailed as a breakthrough, concerns are growing over its affordability and accessibility, especially outside the U.S. The drug is priced at over $28,000 per year in the American market, a cost that is simply out of reach for most low- and middle-income countries.

To tackle this, Gilead Sciences—the company behind Lenacapavir—has signed royalty-free licensing agreements with six Indian generic manufacturers. These include companies like Dr. Reddy’s, Hetero, and Viatris (formerly Mylan). These partnerships aim to supply cheaper versions of the drug to over 120 countries, including many with high HIV burdens. Experts estimate that Indian-made generics could be priced between $100 and $300 per year, making it far more accessible.

However, India’s public health advocates are concerned about Gilead’s patent filings on certain salt forms of Lenacapavir. They argue these patents are not innovative and could delay generic production until 2038. Activists are calling on Indian authorities to reject these patent claims or fast-track regulatory approvals to avoid unnecessary delays in making the drug widely available.

Given India’s robust pharmaceutical industry and track record in HIV drug production, experts believe the country is in a unique position to lead the way. Ensuring equitable and timely access to Lenacapavir could not only benefit millions at risk but also reinforce India’s role as a global supplier of affordable healthcare solutions.

Global health organizations like UNAIDS have welcomed the FDA’s approval, calling it a “milestone” in the fight to end HIV. But they also stress that the drug’s true impact will depend on how quickly and fairly it reaches people who need it most.