US FDA Approves New HIV Prevention Drug, Calls for Improving Access to Lenacapavir Get Louder
Newsletter Edition #279 [The Files In-Depth]
Hi,
In today’s edition, we bring you a quick wrap on how actors in global health are responding to the US FDA decision on approving HIV prevention drug Lenacapavir.
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I. STORY OF THE WEEK
US FDA Approves New HIV Prevention Drug, Calls for Improving Access to Lenacapavir Get Louder
Below is a quick read through on the various stakeholders suggesting the way ahead to make lenacapavir available through diversified manufacturing and cheaper access.
WHO: FDA approval of injectable lenacapavir marks progress for HIV prevention
“The World Health Organization (WHO) welcomes the approval by the United States Food and Drug Administration (FDA) of injectable lenacapavir for HIV prevention.
This milestone follows promising 2024 results from the PURPOSE 1 and PURPOSE 2 trials, which demonstrated the safety and efficacy of lenacapavir across diverse populations and settings. Administered just twice a year, lenacapavir offers sustained protection and adds to the growing range of HIV prevention options.
WHO currently recommends oral PrEP, the dapivirine vaginal ring, and long-acting injectable cabotegravir (CAB-LA) as options for HIV pre-exposure prophylaxis (PrEP). Lenacapavir’s discreet, long-acting formulation may help overcome key barriers such as daily pill burden, frequent clinic visits, and stigma associated with HIV prevention.
“This regulatory milestone brings us one step closer to expanding access to an innovative HIV prevention option in lenacapavir,” said Dr Meg Doherty, Director of WHO’s Global HIV, Hepatitis and STI Programmes. “WHO plays a key role in supporting countries through guideline development, prequalification, and regulatory processes. We are working with partners and national authorities to ensure lenacapavir reaches people who need it most – quickly, safely and equitably.”
WHO guidelines for injectable lenacapavir will be released on 14 July 2025, during the International AIDS Conference in Kigali.
FDA approval also paves the way for WHO prequalification, which can accelerate national regulatory approvals following endorsement by a stringent regulatory authority (SRA) and procurement by donor agencies like the the Global Fund. In parallel, WHO is working with the European Medicines Agency (EMA) to support the Medicines 4 All (M4All) mechanism, which facilitates regulatory pathways in countries adopting lenacapavir.”
UNAIDS urges Gilead to drop price:
“The United States Food and Drug Administration (FDA) has approved long-acting injectable lenacapavir for HIV prevention. The new medicine is administered by injection once every 6 months and is a significant step in improving prevention options for people at risk of HIV infection around the world. In an interview with the New York Times, Gilead Sciences has announced a US list price of $28,218 USD per person per year.
In a research paper published in The Lancet HIV this week, experts found that generic lenacapavir could cost $35-$46 per person-year. This could fall to $25 per person-year for a committed demand of five to ten million people within the first year, bringing pricing in line with or lower than current oral PrEP.
Responding to news of Lenacapavir’s FDA approval, Winnie Byanyima, Executive Director of UNAIDS and United Nations Undersecretary-General, said:
“This is a breakthrough moment. The approval of lenacapavir is a testament to decades of public investment, scientific excellence, and the contributions of trial participants and communities. I congratulate Gilead and U.S. partners for advancing this important innovation. Lenacapavir could be the tool we need to bring new infections under control – but only if it is priced affordably and made available to everyone who could benefit.
“UNAIDS has seen research that lenacapavir can be produced for just $40 per person per year, falling to $25 within a year of roll out. It is beyond comprehension how Gilead can justify a price of $28,218. If this game-changing medicine remains unaffordable, it will change nothing. I urge Gilead to do the right thing. Drop the price, expand production, and ensure the world has a shot at ending AIDS.” "
Experts call for a license via the Medicines Patent Pool
Medicines Law & Policy: FDA approval of injectable lenacapavir for Pre-Exposure Prophylaxis (PrEP) opens the road to ending HIV
“…The MPP has flagged the product as one of interest and mapped the patent situation: LEN primary patents have been filed or granted in several low and middle-income countries (LMICs) and are expected to expire between 2034 and 2037. Gilead also holds secondary patents that may provide exclusivity until 2038 in many LMICs. Patent oppositions have been filed in several countries, including in India, Indonesia, Armenia, Belarus, Kazakhstan, Kyrgyzstan, Vietnam, Argentina and Thailand.
However, Gilead decided not to work with the MPP and, in October 2024, concluded bilateral licensing agreements with six generic manufacturers for the production and supply of LEN, allowing for sales for the treatment and prevention of HIV in 120 countries. Now the FDA has approved LEN-LA for PreP, licensees will be able to produce the product and supply it in the territories designated as eligible by Gilead. The licence excludes many countries in Latin America and Eastern Europe. It is unfortunate that Gilead did not collaborate with the MPP on its licensing strategies. For example, an MPP licence would have left the option open for supply by the generic licensee to countries outside the territory when there are no patent barriers, such as in the case of a compulsory license or if patents do not exist (including if one of the patent oppositions is successful). Health Gap published a useful brief on the patent issues related to LEN supply.
In July 2024, a study by Fortunak et al. showed that LEN’s cost-plus price for PrEP can be as low as US$35-US$40 per patient per year (pppy) provided it is produced at a large scale, which will decrease the cost of the active pharmaceutical ingredient. The authors conclude that ”mass-production of generic lenacapavir, under voluntary licensing, is required to achieve this.” A more recent estimate put the possible price at US$25 per injection once economies of scale are reached. The current list price for LEN used in HIV treatment is US$39,000 pppy. The New York Times reported that in the US, the list price for lenacapavir for PrEP, will be US$28,218.
Demand for the product will be key in creating economies of scale large enough to drive the price down to this level. And creating demand requires financing for procurement and supply. The dwindling global health financing and in particular the defunding of USAID and PEPFAR may therefore pose a serious threat to the uptake of the product and thus to the very real opportunity to end HIV.
Gilead is expected to publish its access strategy for LEN-LA when it obtains FDA approval. Collaboration with the MPP should be central in this strategy. Access to a product that has the potential to end HIV requires access to all and access everywhere.”
On expanding production:
Matthew M. Kavanagh, director of the Center for Global Health Policy & Politics at the O’Neill Institute and Georgetown School of Health:
“Long-acting antiretrovirals could revolutionize the global response to AIDS. On average, research shows HIV innovations become widely available in the United States 10 years before they are in Africa. But this drug could be made affordably in factories in South Africa, Brazil, Thailand, and beyond. If that happens, and happens fast, it could be a major salve for the global crisis in HIV today.
In the short term, Gilead committed to selling 2 million doses now to PEPFAR and the Global Fund, and it is essential that the irresponsible cuts to US aid programs do not derail this effort and that those 2 million doses reach people in need,” added Kavanagh. “Notwithstanding cutbacks at PEPFAR and the Global Fund, it is essential to ensure that Gilead’s interim commitment of 2 million doses gets administered to those who need them as we work to bring generic production online.”
What activists say needs to be done:
Public Citizen: Making Long-Acting PrEP Accessible to All Could Help End AIDS
“…Patented in many Latin American countries, lenacapavir as an HIV treatment is priced at more than $40,000 (U.S. dollars) per year, but experts estimate lenacapavir’s production (plus a margin for profit) could price the drug as low as $25 with process improvements and an increase in demand. Gilead, owner of the patents, has licensed the production of the generic version to supply 120 countries, excluding most Latin American countries; even those where the respective clinical trials were carried out and in countries with rising HIV incidence – the region has seen a 9% increase in new HIV infections between 2010 and 2023.
Public Citizen has been working with 100 health groups across Latin America to overcome the patent barrier, issuing multiple compulsory license requests and calling on governments to take action to make long-acting PrEP more accessible. This week groups submitted letters to Gilead, government officials and ministries of health and patent offices.
Public Citizen Access to Medicines Director Peter Maybarduk said governments and manufacturers must prioritize meeting the global need to prevent HIV transmission.
“Gilead excluded most of Latin America from its license, but countries have the power to introduce affordable generics nonetheless, overcome the patent barrier and scale up PrEP,” said Maybarduk. “The world has an historic opportunity to end AIDS. That requires confronting the triple threat of funding cuts, stigma and pharma power.”
“This scientific breakthrough will only be meaningful if it becomes available in a timely, affordable, and equitable manner for all who need it across Latin America and the Caribbean. Access barriers in our region are not only ethically unacceptable—they undermine global efforts to end AIDS,” said Luz Marina Umbasia, Director of Global Humanitarian Progress Colombia.
“Equity in access and affordability is the only path to realizing the full lifesaving potential of long-acting antiretrovirals. Sharing technology and opening patents can expand markets and save lives—but only if done fairly and consistently, without excluding regions like Latin America and the Caribbean. It’s time for Big Pharma to move beyond an outdated, monopolistic patent model. The world can no longer afford business as usual,” said Guillermina Alaniz, Director of Global Advocacy & Policy at the AIDS Healthcare Foundation.”
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