The European Medicines Agency (EMA) has recommended approving a twice-yearly injectable medication designed to prevent HIV transmission. Scientists say this drug could be a game-changer in efforts to halt the spread of the virus.
In a statement on Friday, the EMA said its evaluation of lenacapavir, marketed as Yeytuo by Gilead Sciences in Europe, found the drug to be “highly effective” and “considered to be of major public health interest.” Once the European Commission endorses the recommendation, the authorization will apply across all 27 European Union member states, as well as Iceland, Norway, and Liechtenstein.
Clinical Effectiveness and Global Impact
Lenacapavir is already approved for treating HIV, but last year’s studies showed it was nearly 100% effective at preventing transmission in both men and women. Winnie Byanyima, executive director of the United Nations AIDS agency UNAIDS, stated that the drug “could change the trajectory of the HIV epidemic” if it becomes widely accessible.
The U.S. Food and Drug Administration authorized lenacapavir for HIV prevention in June, and earlier this month the World Health Organization recommended countries offer the drug as an additional prevention option.
Current prevention methods include condoms, daily oral pills, and injectable drugs like cabotegravir, which requires dosing every two months. Lenacapavir offers protection for six months, making it the longest-lasting option. This could appeal to those who are hesitant about frequent clinic visits or the stigma associated with daily medication.
Access and Equity Concerns
Despite its promise, critics worry lenacapavir won’t be sufficiently accessible to stop global HIV outbreaks. Gilead has pledged to allow affordable generic versions in 120 low-income countries with high HIV prevalence—mostly in Africa, Southeast Asia, and the Caribbean. However, nearly all of Latin America, where HIV rates are lower but rising, has been excluded from this plan, raising concerns about missed opportunities in the fight against HIV.
According to UNAIDS, about 630,000 people died from AIDS-related causes worldwide last year, with more than 40 million people currently living with HIV.
UNAIDS chief Winnie Byanyima has urged President Donald Trump to negotiate with Gilead for a global license to produce lenacapavir, ensuring millions who need it can access this “magical” prevention drug.
What The Author Thinks
Lenacapavir represents a significant advance in HIV prevention, but its true potential hinges on global accessibility. Restricting generic availability in regions like Latin America threatens to undermine worldwide efforts to control the epidemic. Drugmakers and governments must collaborate urgently to ensure equitable distribution. Without broad access, we risk leaving behind vulnerable populations and prolonging a public health crisis that science has the tools to end.
Featured image credit: NIAID via Flickr
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