The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended approval of Gilead Sciences’ lenacapavir, a twice-yearly injection for preventing HIV infection.
If the recommendation is followed by the European Commission (EC), lenacapavir would become the EU’s first HIV prevention medicine not administered on a daily, weekly, or monthly basis.
Following the announcement, shares in US-listed Gilead closed 1.4% higher on 25 July. The company has a market cap of $144.5bn.
Marketed under the European brand name of Yeytuo, the drug would be indicated as a pre-exposure prophylaxis (PrEP) option in combination with safer sex practices to reduce the risk of HIV-1 infection in adults and adolescents at high risk of becoming infected. It works by inhibiting HIV-1 viral replication in the body.
Twice-yearly injectable lenacapavir has already been approved in the US, with the Food and Drug Administration (FDA) approving the medicine last month. It is known under the brand name Yeztugo in the US.
The positive opinion issued by the CHMP was based on data from two Phase III trials conducted by Gilead, namely PURPOSE 1 and PURPOSE 2. In the PURPOSE 1 trial (NCT04994509), data showed zero HIV infections among 2,134 participants receiving Yeytuo.
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By GlobalDataThe group taking Gilead’s drug demonstrated higher HIV prevention over those trial receiving the daily pill Truvada. In the PURPOSE 2 trial (NCT04925752), there were only two HIV infections among 2,179 participants in the twice-yearly subcutaneous lenacapavir group, meaning 99.9% of participants did not acquire HIV infection.
In a Gilead statement, Université Paris Cité infectious diseases professor Jean-Michel Molina said: “These positive opinions from the CHMP are an important step toward a new HIV prevention option that could help meet the diverse needs of people across Europe and aim at helping end new HIV infections by the EU target of 2030.
“The opinions reflect the strength of the clinical evidence and the potential of long-acting innovations like lenacapavir to address real-world barriers to the use of PrEP. Expanding the range of PrEP options, in Europe and in countries around the world, is essential to making HIV prevention more accessible for people who need it most.”
HIV-1 infection is a major driver of global healthcare burden. According to the World Health Organization (WHO), an estimated 1.3 million people became newly infected with HIV in 2024. This includes 650,000 people in Africa, the region most affected by HIV. Treatment efforts for the infectious disease have been curbed by cuts in international aid and prevention programmes.
Earlier this month, the WHO endorsed injectable lenacapavir as a powerful tool in reducing HIV cases. Lenacapavir was first approved in 2022 under the brand name Sunlenca for the treatment of HIV infection in adults with multi-drug resistance. The injectable version has been heralded as a historical breakthrough by HIV experts and charities because it offers a more accessible option for patients.
The WHO adds that the vaccine offers a highly effective, long-acting alternative to daily oral pills and other shorter-acting options.
The EMA said that Yeytuo is “highly effective” at preventing HIV and can “facilitate PrEP uptake and compliance”.
GlobalData analysts stated that the first regulatory approval of the drug in the US was a “momentous step in improving PrEP options available for people vulnerable to contracting HIV”.
