The US Food & Drug Administration has approved a generic version of lenacapavir (Yeztugo), 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, reports MedPage Today.
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.
“People don’t always take their daily dose of medication, and if you don’t take it, you cannot get protected against HIV,” said Carmen Pérez Casas, MSc, HIV lead for the grant-making organisation Unitaid. “With lenacapavir, we are much more hopeful.”
Ultimately, advocates believe the medication should help drive down cases of HIV and Aids – and deaths. The WHO said that globally, 41m people are HIV+ and 570 000 died from HIV-related causes last year.
Now, with an affordable, high-quality generic pre-exposure prophylaxis (PrEP) medication being available, “we could help to scale this to the 20m people around the world who need PrEP”, said Carolyn Amole, who leads the HIV programme for the Clinton Health Access Initiative, “and actually begin to bring an end to the HIV epidemic.”
Generic lenacapavir can’t be sold in the US because the brand-name version, made by Gilead Sciences, 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.
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.
FDA approval 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. Demand has outstripped supply in low- and middle-income countries, though Gilead has established royalty-free licensing agreements with six generic manufacturers to enable greater production. Those voluntary licenes cover a specific set of countries in sub-Saharan Africa, Asia, and Latin America.
The generic was developed by India-based Dr Reddy’s Laboratories under an agreement brokered by Unitaid, the Clinton Health Access Initiative, and South Africa’s Wits RHI. The partners sought to accelerate development and make the drug available at an affordable price.
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 the FDA.
“The work is not done. Now, we need the funding to actually buy it for everyone who needs it, and then we need to do the hard work of getting it to the millions of people who need it and want it,” Amole said. “But this is a great milestone.”
Casas said she’s optimistic that scientific advances – along with political will and funding – can help the world curb HIV.
See more from MedicalBrief archives:
Donors enable deal for $40 generic anti-HIV ‘miracle’ drug
Minister promises SA-made generic as LEN rollout begins
Demand for new HIV jab outstrips supply in African rollout
Gilead inks deal for generic HIV drug supply to low-income nations