EU REGULATOR APPROVES INJECTABLE HIV DRUG AIMED AT PREVENTING TRANSMISSION. (PHOTO).

 EU regulator approves injectable HIV drug aimed at preventing transmission

The European Medicines Agency has recommended the approval of a twice-yearly injectable drug designed to prevent HIV infection, a development that researchers believe could significantly curb transmission of the virus. The drug, lenacapavir, which will be marketed in Europe under the name Yeytuo by Gilead Sciences, was described by the agency as “highly effective” and of “major public health interest.” If the European Commission accepts this guidance, the authorization will apply across all 27 EU countries, as well as Iceland, Norway, and Liechtenstein. Clinical studies conducted last year showed that lenacapavir, already used to treat individuals living with HIV, was almost 100% effective in preventing transmission in both men and women.

Public health officials, including Winnie Byanyima, the executive director of the United Nations AIDS agency, have described lenacapavir as a potential game changer in the fight against HIV, provided that it is made widely accessible. The drug, which was authorized for prevention by the U.S. Food and Drug Administration in June, has also been recommended by the World Health Organization as an additional option for people at risk. Unlike daily preventive pills or cabotegravir injections that must be administered every two months, lenacapavir provides protection for six months with a single injection, a feature that could appeal to those who prefer fewer clinic visits and less stigma. Despite its promise, critics have expressed concerns that Gilead’s plan to allow generic production in 120 low-income countries does not cover much of Latin America, where HIV rates, though lower, are rising. UNAIDS estimates that more than 40 million people worldwide live with HIV, with about 630,000 deaths from AIDS-related illnesses reported last year, and has urged global leaders, including President Donald Trump, to work toward making this long-lasting prevention option accessible to those who need it most.