Louisville: The US Food and Drug Administration (FDA) has granted tentative approval to an India-manufactured generic version of lenacapavir, the world's only twice-a-year shot to prevent HIV, marking 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 organisations that helped to speed up development of the medication, called lenacapavir.
The generic was developed by India-based Dr. Reddy's Laboratories 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 the drug available at an affordable price.
Drug to cost $40 a year per person
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 organisation Unitaid, a global health agency. “With lenacapavir, we are much more hopeful.”
Medication to drive down cases of HIV
Ultimately, advocates said, the medication should help drive down cases of HIV and AIDS - and deaths.
According to the WHO, 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 programme for the Clinton Health Access Initiative, a global health organisation.
“And if we scale to those levels,” she added, “we can actually begin to bring an end to the HIV epidemic.”
FDA approval to benefit low, middle income countries
Generic lenacapavir can't be sold in the US because a brand-name version, Yeztugo, made by Gilead Sciences and approved last year, is still protected by a patent. The US 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 US government. Approval of a drug by the US FDA can speed regulatory approval in many other countries. The approval is considered “tentative,” the FDA's standard designation for generics while the originator remains under patent.
Until now, Gilead has been the sole supplier of lenacapavir, and demand has outstripped supply in low- and middle-income countries. Last year, Gilead established royalty-free licensing agreements with six generic manufacturers to enable production. Those voluntary licenses cover a specific set of countries in sub-Saharan Africa, Asia and Latin America.
“We share the sense of urgency around expanding access to lenacapavir for HIV prevention,” a Gilead spokesperson said in a statement. “We believe we have enabled the fastest and most sustainable path to expanding access for communities most affected by HIV.”
Generic lenacapavir should start to become available in some places within weeks, those helping with the effort said, although it could take a bit longer in countries that require the drug to go through their own approval processes before people can start taking it. Generic versions made by the other manufacturers have yet to be approved by FDA.
