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EU regulator green lights an injectable HIV drug that could help stop transmission

This colorized electron microscope image provided by the U.S. National Institutes of Health shows a human T cell, in blue, under attack by HIV, in yellow, the virus that causes AIDS. (Seth Pincus, Elizabeth Fischer, Austin Athman/National Institute of Allergy and Infectious Diseases/NIH via AP, File)

Key Points

  • The European Medicines Agency has recommended authorizing lenacapavir (sold as Yeytuo) as a twice-yearly injectable for HIV prevention, pending European Commission approval across all EU member states plus Iceland, Norway and Liechtenstein.
  • Clinical data show lenacapavir is nearly 100% effective at stopping HIV transmission and offers the longest-lasting protection—six months—compared with daily pills or two-monthly injectables.
  • Lenacapavir was authorized by the U.S. FDA in June and is backed by a World Health Organization recommendation, with the U.N. AIDS agency calling it a potential game-changer in ending the epidemic.
  • Critics warn that access may be uneven: Gilead’s royalty-free licensing covers 120 low-income countries but largely excludes Latin America, sparking concerns about global equity in HIV prevention.
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LONDON (AP) — The European Medicines Agency has recommended authorizing a twice-yearly injectable drug aimed at preventing HIV, which scientists say could help end the virus' transmission.

In a statement on Friday, the EU drug regulator said its evaluations of lenacapavir, sold as Yeytuo in Europe by Gilead Sciences, showed the drug is “highly effective” and “considered to be of major public health interest.” Once the regulator's guidance is accepted by the European Commission, the authorization is valid in all 27 EU member countries as well as Iceland, Norway and Liechtenstein.

Last year, studies suggested that lenacapavir, already used to treat people with HIV, was nearly 100% effective in stopping transmission in both women and men.

Winnie Byanyima, executive director of the U.N. AIDS agency, has said the drug “could change the trajectory of the HIV epidemic” if it is made available to everyone who needs it.

In June, the U.S. Food and Drug Administration authorized lenacapavir to prevent HIV. Earlier this month, the World Health Organization recommended countries offer the drug as an additional option to people at risk of the virus.

Condoms help guard against HIV infection if used properly. Other medication aimed at preventing HIV include daily pills that people can take and another injectable drug called cabotegravir, which is given every two months. Lenacapavir’s six-month protection makes it the longest-lasting type, an option that could attract people wary of more visits to health clinics or stigma from taking daily pills.

Critics have raised concerns, however, that lenacapavir may not be made widely enough available to stop global outbreaks of HIV. Drugmaker Gilead has said it will allow cheap, generic versions to be sold in 120 poor countries with high HIV rates — mostly in Africa, Southeast Asia and the Caribbean.

But it has excluded nearly all of Latin America, where rates are far lower but increasing, sparking concern the world is missing a critical opportunity to stop the disease.

Last year, there were about 630,000 AIDS deaths worldwide and more than 40 million people are estimated to have HIV, according to UNAIDS.

UNAIDS chief Byanyima has previously suggested that President Donald Trump make a deal with Gilead to produce and license its “magical” prevention drug lenacapavir across the world to the millions of people who need it.

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The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute’s Department of Science Education and the Robert Wood Johnson Foundation. The AP is solely responsible for all content.

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