Lenacapavir: After FDA approval, HIV pre-exposure prophylaxis injectable moving closer to EU approval
The European Medicines Agency has recommended Gilead Sciences' Lenacapavir, a twice-yearly injectable for HIV prevention, following its recent FDA approval. Clinical trials showed high efficacy in preventing HIV infection among diverse populations in Africa.
Why it matters
This new drug offers a significant advancement in HIV prevention, potentially increasing adherence and uptake compared to daily oral medications.
On July 25, The European Medicines Agency (EMA)’s advisory committee recommended Gilead Sciences’ Lenacapavir, a twice-yearly injection, for preventing HIV infection in adults and adolescents. Any recommendation by EMA’s advisory committee has to be formally approved by the European Commission, which is expected later this year. The recommendation by the EMA’s advisory committee comes about a month after the U.S. FDA on June 18, 2025 approved the injectable HIV-1 capsid inhibitor as a pre-exposure prophylaxis (PrEP).
The article relies on clinical trial data and regulatory announcements to report on a medical development.
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