On June 18, the U.S. Food and Drug Administration approved long-acting injectable lenacapavir for HIV prevention. A month later, the European Medicines Agency recommended its authorization, which was officially formalized by the European Commission last week. In Europe, the drug will be marketed under the name Yeytuo, and its availability will now depend on price and reimbursement negotiations in each country.
This is a historic breakthrough, as lenacapavir is the first pre-exposure prophylaxis (PrEP) option that can be administered only twice a year—a tool that could mark a turning point in the fight against HIV. Clinical trials have shown that it provides near-complete protection against infection. This advance is especially important for cisgender women in sub-Saharan Africa, sex workers, LGTBIQ+ people, and people who use drugs—groups for whom existing tools such as daily oral PrEP or condoms have not been sufficiently effective.
However, this potential risks being restricted to very few people, even in high-income countries where the price will pose a major barrier to access. Last year, we already warned that the voluntary license promoted by the company was not enough. Added to this is the fact that Gilead will remain the sole global supplier of the drug until 2027, meaning that its decisions on pricing, registration, and transparency will directly impact global access.
Registration: a bottleneck
Regulatory approval in each country is a prerequisite for HIV programs to roll out lenacapavir on a large scale. But Gilead has prioritized submissions in the most profitable markets (such as the United States, the European Union, the United Kingdom, Australia, and Canada), where the drug may be priced at over $28,000 per person per year.
This is despite independent studies showing that lenacapavir could be manufactured for as little as $25 per year if generics and large-scale production were available.
Meanwhile, the situation in low- and middle-income countries remains unclear and troubling. Of the countries that participated in the PURPOSE clinical trials, only South Africa and Brazil have received registration submissions, both still pending approval. Although Gilead announced a group of “priority countries” in Africa and Asia, so far only South Africa has a formal application in process.
At the same time, the EU’s accelerated approval pathway (EU-Medicines for All) covers just eight countries, leaving out most of those hardest hit by the epidemic.
Lack of transparency and delays
Together with other civil society organizations worldwide, Salud por Derecho has denounced Gilead’s lack of transparency around its regulatory and pricing plans. Despite having the option, the company has not yet applied for World Health Organization (WHO) prequalification—a critical step to speed up availability in low- and middle-income countries. Nor has it committed to the WHO Collaborative Registration Procedure, which would allow national approvals in as little as 90 days.
The absence of these mechanisms means that most countries will face lengthy, fragmented processes, with direct consequences for health, since every delay translates into infections that could have been prevented. In May, global estimates of new HIV infections rose from 3,500 to 5,800 per day, underscoring the urgency of making new prevention tools available.
Letter to Gilead
Last August, Salud por Derecho, together with an international coalition of 278 organizations and individual signatories—including Health GAP, Public Citizen, Doctors Without Borders, ABIA Brazil, Health Justice Initiative, and Treatment Action Campaign—sent a letter to Gilead CEO Daniel O’Day demanding that the company:
- Accelerate regulatory submissions in all low- and middle-income countries.
- Publish the list of countries included in the EU-Medicines for All pathway.
- Urgently apply for WHO prequalification and make use of the collaborative registration procedure.
- Ensure affordable and transparent pricing.
Lenacapavir has the potential to transform HIV prevention. But for that promise to be fulfilled, Gilead must take responsibility by speeding up registration processes, offering fair prices, and acting with full transparency. Otherwise, we risk seeing a revolutionary tool reserved for a privileged few, when what is needed is a global, urgent, and equitable response.
