FDA tentatively approves generic lenacapavir to expand global HIV prevention access

The twice-yearly generic is expected to cost $40 per person annually

The U.S. Food and Drug Administration granted tentative approval to a generic version of lenacapavir, the world’s only twice-a-year HIV prevention injection, clearing a regulatory step toward lower-cost and faster availability in 120 low- and middle-income countries. Dr. Reddy’s Laboratories and the organizations that helped accelerate the drug’s development announced the decision Monday morning. The generic is expected to cost $40 per person each year in the countries where it will be available.

Tentative approval opens a regulatory route

The FDA granted the tentative approval through a longstanding practice designed to ensure the quality of HIV-related drugs provided to other countries by the U.S. government. Approval of a drug by the FDA can speed regulatory approval in many other countries. The agency calls the authorization “tentative,” its standard designation for generics while an originator product remains under patent.

India-based Dr. Reddy’s Laboratories developed the generic under an agreement brokered by Unitaid, the Clinton Health Access Initiative and Wits RHI, a health research institute in Africa. The partners sought to accelerate development and make lenacapavir available at an affordable price.

Pricing, patents and licensing shape access

The generic is expected to cost $40 per person each year in the countries where it will be available, the same price as daily preventive pills available now. Lenacapavir injections are more convenient because they are needed much less frequently, and they nearly eliminated new infections in two studies of people at high risk.

People do not always take their daily dose of medication, “and if you do not take it, you cannot get protected against HIV,” said Carmen Pérez Casas, HIV lead for the grant-making organization Unitaid, a global health agency. She added, “With lenacapavir, we are much more hopeful.”

The generic cannot be sold in the United States because Yeztugo, the brand-name version made by Gilead Sciences and approved last year, remains protected by a patent. The U.S. list price for Yeztugo, meaning the cost before insurance, is $28,218 a year. Gilead officials said that amount is similar to the cost of some other forms of PrEP, which stands for pre-exposure prophylaxis.

Before the tentative approval, Gilead had been the sole supplier of lenacapavir, and demand had outstripped supply in low- and middle-income countries. Last year, Gilead established royalty-free licensing agreements with six generic manufacturers to enable production. The voluntary licenses cover a specific set of countries in sub-Saharan Africa, Asia and Latin America. Generic versions made by the other manufacturers have yet to receive FDA approval.

“We share the sense of urgency around expanding access to lenacapavir for HIV prevention,” a Gilead spokesperson said in a statement. The spokesperson also said, “We believe we have enabled the fastest and most sustainable path to expanding access for communities most affected by HIV.”

Safety rules require HIV testing

Common side effects of lenacapavir include injection-site reactions, headache and nausea. People must be tested for HIV before starting the drug and with each injection because drug-resistant HIV has been identified when lenacapavir was used by people with an undiagnosed HIV infection.

Saiqa Mullick, director of implementation science with Wits RHI, said, “For any kind of PrEP … you need to have HIV testing in advance.” Mullick added, “For many of the low- and middle-income countries, that is a rapid test.”

Rollout still depends on funding and delivery

Those helping develop generic lenacapavir said it should start becoming available in some places within weeks. Availability could take longer in countries that require the drug to pass through their own approval processes before people can start taking it.

Ultimately, advocates said, the medication should help drive down cases of HIV and AIDS — and deaths. According to the World Health Organization, 41 million people worldwide were living with HIV and 570,000 died from HIV-related causes last year.

With an affordable generic medication now available, Carolyn Amole, who leads the HIV program for the Clinton Health Access Initiative, a global health organization, said, “we could help to scale this to the 20 million people around the world who need PrEP.” PrEP is prescription medicine taken by people at risk of HIV before they are exposed to the virus. “And if we scale to those levels,” Amole added, “we can actually begin to bring an end to the HIV epidemic.”

Amole said the approval did not resolve the remaining work: “The work is not done. Now, we need the funding to actually buy it for everyone who needs it and then we need the hard work of getting it to the millions of people who need it and want it.” She added, “But this is a great milestone.”

Pérez Casas said she was optimistic that scientific advances, political will and funding could help the world curb HIV. “Now,” she said, “we have the tools.”

Source credit and funding

Laura Ungar wrote the story, with Gerald Imray in Cape Town, South Africa, contributing. The Associated Press’ health and science coverage receives financial support from the AP Fund for Journalism and private foundations. AP is solely responsible for all content.