The United States Food and Drug Administration has granted approval to a generic version of lenacapavir, a twice-yearly injection used to prevent HIV infection, paving the way for more affordable access in 120 low- and middle-income countries.
The announcement was made on Monday by the drug manufacturer and organisations involved in accelerating the development of the medication.
The generic injection is expected to cost about $40 per person annually in the countries covered by the arrangement, matching the price of existing daily HIV prevention pills.
However, health advocates say the injection could improve prevention efforts because recipients only need two doses a year, unlike the pills that must be taken every day.
Lenacapavir nearly eliminated new HIV infections in two major clinical studies involving people at high risk of contracting the virus.
Carmen Pérez Casas, HIV lead at global health agency Unitaid, said the injection offered greater hope because some people struggle to maintain a daily medication routine.
“People don’t always take their daily dose of medication, ‘and if you do not take it, you cannot get protected against HIV,’” she said. “With lenacapavir, we are much more hopeful.”
Advocates believe wider access to the medication could help reduce HIV infections, AIDS-related illnesses and deaths. The World Health Organization estimates that 41 million people were living with HIV globally last year, while 570,000 died from related causes.
Carolyn Amole, who leads the HIV programme at the Clinton Health Access Initiative, said the availability of an affordable generic version could expand access to pre-exposure prophylaxis, commonly known as PrEP.
PrEP is medication taken by people who are at risk of contracting HIV to reduce their chances of infection before exposure to the virus.
“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,’” Amole said.
“And if we scale to those levels,” she added, “we can actually begin to bring an end to the HIV epidemic.”
The generic version will not be available for sale in the United States because Gilead Sciences, the maker of the branded version known as Yeztugo, still holds patent protection for the drug. The FDA approved Yeztugo last year.
The branded injection has a US list price of $28,218 annually before insurance coverage. Gilead officials have maintained that the cost is comparable to that of some other PrEP options.
The latest approval was granted under an established FDA programme intended to ensure the quality of HIV-related medicines supplied to other countries with support from the US government.
Although the approval is classified as “tentative” because the original product remains under patent, the designation can help accelerate regulatory clearance in other countries.
Gilead had previously been the only supplier of lenacapavir, but demand in low- and middle-income countries has exceeded available supplies.
To increase production, the company has entered into royalty-free licensing agreements with six generic drug manufacturers. The agreements cover selected countries across sub-Saharan Africa, Asia and Latin America.
