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The U.S. Food and Drug Administration has approved a generic version of the world's only twice-a-year shot to prevent HIV -- a big step toward making the drug available inexpensively and more quickly in 120 low- and middle-income countries.
The announcement was made on Monday morning by the manufacturer and organizations that helped to speed up development of the medication, called lenacapavir.
The drug is expected to cost $40 a year per person in the countries where it will be available, the same price as daily preventive pills available now. But the shots are much more convenient than the pills because they're needed much less frequently and they nearly eliminated new infections in two groundbreaking studies of people at high risk.
People don't always take their daily dose of medication, "and if you do not take it, you cannot get protected against HIV," said Carmen Perez Casas, HIV lead for the grant-making organization Unitaid, a global health agency. "With lenacapavir, we are much more hopeful."
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, high-quality generic medication now available, "we could help to scale this to the 20 million people around the world who need PrEP," prescription medicine taken by people at risk of HIV before being exposed to the virus, said Carolyn Amole, who leads the HIV program for the Clinton Health Access Initiative, a global health organization.
"And if we scale to those levels," she added, "we can actually begin to bring an end to the HIV epidemic."
Generic lenacapavir can't be sold in the U.S. because a brand-name version, Yeztugo, made by Gilead Sciences and approved last year, is still protected by a patent. The U.S. list price for that version, meaning the cost before insurance, is $28,218 a year. Gilead officials say that's similar to some other types of PrEP, which stands for pre-exposure prophylaxis.
The new generic was approved by the FDA under 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 U.S. FDA can speed regulatory approval in many other countries.