A generic version of an injectable drug for HIV prevention gained tentative approval from the US Food and Drug Administration (FDA) yesterday, marking an important milestone in the global fight against AIDS.
Developed by Hyderabad-based Dr. Reddy’s Laboratories, the long-acting pre-exposure prophylaxis (PrEP) generic is based on Gilead’s lenacapavir. It requires people to receive just one injection every six months.
FDA approval means the generic can now be prescribed in low- and middle-income countries for just $40 a year. Initial supplies are expected to reach countries by the end of the year, according to a press release from Unitaid, a global health agency that’s affiliated with the World Health Organization (WHO).
It can be hard for people to take a pill every day to prevent a disease they don’t have, said Neil Buddy Shah, MD, CEO of the Clinton Health Access Initiative (CHAI), which helped develop the generic.
“Two injections a year, of a product that is almost 100% effective at preventing HIV, changes that entirely,” he said.
Next hurdle: Getting the drug into arms of patients
People who are at risk for contracting HIV take PrEP, as the medication stops HIV from replicating, which allows a person’s immune system to clear the virus before it establishes itself.
Two injections a year, of a product that is almost 100% effective at preventing HIV, changes that entirely.
Often PrEP comes in the form of a daily pill, though last year the FDA approved lenacapavir to be used as a long-acting injectable version. The drug was already in use since 2022 as a treatment for multidrug-resistant HIV.
Because Gilead holds the patent on lenacapavir, the Dr. Reddy’s generic version isn’t available in the United States. Gilead established a royalty-free voluntary license for lenacapavir in 2024 with six generic drug makers to expand access to injectable PrEP in resource-limited countries.
While FDA approval of generic lenacapavir is a major step, it does not guarantee that everyone who needs it will get it, cautioned Rachel Vreeman, MD, dean for Global Health at the Icahn School of Medicine at Mount Sinai.
“Even a cheap drug needs someone to pay for it, and for staff and systems to deliver it,” she told CIDRAP News.
Even a cheap drug needs someone to pay for it, and for staff and systems to deliver it.
The next critical step will be for large orders of the generic to be placed by the US government and the Global Fund to Fight AIDS, Tuberculosis and Malaria, said Vreeman, since commitment to funding HIV prevention is essential in the distribution of this medication.
Some 570,000 people died of HIV-related illnesses last year, according to the WHO. The highest incidence of the virus is in sub-Saharan Africa, where 50% of all new HIV infections globally occur.