FDA approves generic HIV shot for low-income markets

The U.S. Food and Drug Administration approved a generic version of lenacapavir, a medication designed to prevent HIV infection. This clearance paves the way for the drug to be distributed cheaply in 120 low- and middle-income countries. Manufacturers and health organizations announced the decision on Monday morning.

The generic formulation is expected to cost $40 per person per year in the target markets. This price point matches the current cost of daily preventive pills. However, the injection regimen requires dosing only twice a year. Two clinical studies showed the shots nearly eliminated new infections among people at high risk.

Carmen Pérez Casas, the HIV lead for the global health agency Unitaid, noted that adherence to daily pills can be difficult. She stated, “and if you do not take it, you cannot get protected against HIV.” Pérez Casas added that the new option brings greater hope for prevention efforts.

The World Health Organization reported that 41 million people worldwide were living with HIV last year. Additionally, 570,000 people died from HIV-related causes during that period. Advocates believe an affordable, high-quality generic will help reduce these numbers.

Carolyn Amole, who leads the HIV program for the Clinton Health Access Initiative, said the medication should help scale pre-exposure prophylaxis, known as PrEP, to 20 million people. She noted, “And if we scale to those levels, we can actually begin to bring an end to the HIV epidemic.”

The brand-name version, Yeztugo, is made by Gilead Sciences and remains protected by a patent in the United States. Its list price is $28,218 a year before insurance. Gilead officials said this price is similar to other PrEP options. The company established royalty-free licensing agreements with six generic manufacturers last year to boost production in sub-Saharan Africa, Asia, and Latin America.

Dr. Reddy’s Laboratories, based in India, developed the approved generic under an agreement brokered by Unitaid, the Clinton Health Access Initiative, and Wits RHI. Common side effects include injection site reactions, headache, and nausea. Patients must test for HIV before starting the drug and with each injection. Saiqa Mullick, a director at Wits RHI, said rapid testing is common in the target countries.

Generic lenacapavir could begin reaching some locations within weeks. Other countries may require their own regulatory approval processes, which could delay availability. Other generic versions are still waiting for FDA approval. Amole said the next step is securing funding to buy the drug for everyone who needs it.