EU regulator green lights an injectable HIV drug that could help stop
transmission
[July 26, 2025]
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.
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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)
 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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