Europe

EU Regulator Backs Twice-Yearly HIV Prevention Injection

JUL 25 2025·Updated JUL 26 2025

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The Facts

The European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use recommended approval of lenacapavir, a twice-yearly injectable drug for HIV prevention, on Friday.
European Medicines Agency (EMA)
Reuters
Lenacapavir demonstrated nearly 100% effectiveness in preventing HIV transmission among male and female populations in two Phase 3 trials called PURPOSE 1 and PURPOSE 2, involving over 4,000 participants across multiple countries.
Gilead
European Medicines Agency (EMA)
ABC News
The drug would be the first twice-yearly HIV prevention option in the European Union if approved by the European Commission, which is expected to make a final decision later this year.
Gilead
Reuters
In 2024, an estimated 1.3 million people became newly infected with HIV globally, including 160,000 new infections in the European region, according to World Health Organization data.
Medscape
European Medicines Agency (EMA)
Gilead Sciences has agreed to allow generic versions of lenacapavir to be sold in 120 lower-income countries with high HIV rates, primarily in Africa, Southeast Asia and the Caribbean. An estimated 630,000 people died of AIDS worldwide last year.
Medscape
NBC
Toronto Sun
The drug will be marketed as Yeytuo in Europe and costs $28,218 per year in the United States, where it received FDA approval in June 2025 under the brand name Yeztugo.
Medscape
EuroNews
Pharmalive

Sources Split

LEFT

CENTER

RIGHT

ESTAB
CRIT

CENTER

PRO
ESTAB

The Spin

Narrative A

This breakthrough represents a game-changing advancement in HIV prevention that could finally help end the epidemic. The twice-yearly injection eliminates barriers like stigma and healthcare access that keep vulnerable populations underserved. With nearly 100% effectiveness proven in trials and WHO endorsement, lenacapavir offers the longest-lasting protection and could expand prevention coverage globally.

The Globalfund

Narrative B

Lenacapavir's impact will be severely limited by accessibility and pricing concerns. At over $28,000 annually in the US, the drug remains prohibitively expensive for most, while Gilead's exclusion of Latin America from generic licensing creates coverage gaps in regions with rising infection rates. Without broader access, this drug risks becoming a life-saving treatment that doesn't reach those most at risk.

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