Islamabad: The Drug Regulatory Authority of Pakistan (DRAP) has registered lenacapavir, a twice-yearly injection that prevents HIV, clearing the way for its local manufacture by Ferozsons Laboratories, though pricing approval could delay its availability, officials say.
DRAP officials said the Registration Board approved the product as a new molecule at its meeting on October 6-7. It will be made for Ferozsons at BF Biosciences in Lahore, using active ingredient imported from the originator, Gilead Sciences.
Lenacapavir is the first drug of its kind, targeting the protective shell around HIV’s genetic material. The US Food and Drug Administration approved it for treatment in 2022 and for prevention in 2025. It is injected under the skin every six months, and the World Health Organization recommended it as an additional prevention option.
Although Pakistan’s epidemic is still officially classified as “concentrated”, meaning it is driven mostly by high-risk groups, but infections are rising, officials say.
An updated UNAIDS estimate suggests around 417,214 people could be living with HIV. Only 92,148 are registered with the national programme and 67,878 are on antiretroviral therapy (ART). Roughly one in five is therefore registered, leaving most undiagnosed.
The Common Management Unit (CMU) of AIDS, TB and Malaria said WHO reported in December 2025 that annual new infections rose from about 16,000 in 2010 to 48,000 in 2024, an increase of roughly 200 percent. It said Pakistan has one of the fastest-growing epidemics in WHO’s Eastern Mediterranean Region.
Children have been hit hard, and according to the National HIV Management Information System, 3,900 children were registered as HIV-positive between January 2025 and June 2026, including 1,915 in Sindh and 1,765 in Punjab. Unsafe injections, weak infection control and unscreened blood transfusions have been blamed.
UNAIDS officials in Islamabad, speaking on condition of anonymity, said the agency pressed for lenacapavir to be brought in quickly because it could help people who struggle with daily pills, stigma or access to healthcare.
In a letter dated September 9, UNAIDS Country Director for Pakistan and Nepal asked DRAP Chief Executive Officer Dr. Obaidullah for fast-track registration.
The letter noted that Gilead has licensed six generic manufacturers, including Ferozsons, to supply 120 high-incidence, resource-limited countries. A DRAP official said the Registration Board took up the application about four weeks after the letter was sent.
But DRAP officials made it clear that registration does not mean production will start now, or that the drug will soon be on pharmacy shelves. Officials and industry sources said the biggest challenge will be getting a price approved by the government, a process that can take months.
Lenacapavir is expensive abroad. In the United States, Gilead’s list price for a year of prevention is reportedly around $28,000, while generic makers have said they expect to supply low- and middle-income countries at about $40 a year. Whether Pakistan’s price will come close is not yet known, nor whether the government or donors will buy it for free distribution.
Two large trials led to the approvals. In the first, which enrolled over 5,300 adolescent girls and young women in South Africa and Uganda, no infections occurred among the 2,134 who received lenacapavir. In the second, covering men, transgender and non-binary people at risk, only two infections occurred among 2,180 participants. Both trials found about 96 percent fewer infections than with a daily oral prevention pill.
Researchers are also testing it for treatment. A study published October 8 in JAMA Network Open, led by Dr. Monica Gandhi of the University of California, San Francisco, followed 46 people who received lenacapavir with another long-acting drug, cabotegravir. Nearly three-quarters had drug resistance, yet after nearly two years all had undetectable viral loads.
Gandhi said clinicians are already using the two drugs together with little evidence to guide them. The study did not compare the combination with other treatments, and the combination is not yet approved.
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