{"id":6446,"date":"2025-08-27T18:31:00","date_gmt":"2025-08-27T18:31:00","guid":{"rendered":"https:\/\/healthcaremagazine.bg\/ec-gives-green-light-to-new-hiv-prevention-therapy\/"},"modified":"2026-05-09T22:51:31","modified_gmt":"2026-05-09T22:51:31","slug":"ec-gives-green-light-to-new-hiv-prevention-therapy","status":"publish","type":"post","link":"https:\/\/healthcaremagazine.bg\/en\/ec-gives-green-light-to-new-hiv-prevention-therapy\/","title":{"rendered":"EC gives green light to new HIV prevention therapy"},"content":{"rendered":"\n<p class=\"wp-block-paragraph\">The European Commission has issued a marketing authorization for the first injectable HIV-1 capsid inhibitor \u2013 <strong>lenacapavir<\/strong>. It will be administered only twice a year, once every six months, announced the manufacturer <em>Gilead<\/em>. The drug will be marketed under the brand name <strong>Yeytuo<\/strong>. It is intended for pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 in adults and adolescents at increased risk. A condition for application is a body weight of over 35 kg.    <\/p>\n\n<p class=\"wp-block-paragraph\"><strong>Yeytuo<\/strong> is the first and only PrEP therapy with a six-month dosing regimen. It has already received approval for use in all 27 EU member states. In addition to these, approval for use has also been granted for the countries of the European Economic Area \u2013 Norway, Iceland, and Liechtenstein.  <\/p>\n\n<p class=\"wp-block-paragraph\">The application was reviewed under an accelerated procedure by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA). The reason is that the medication is of great public health importance. In July, the CHMP issued a positive opinion and recommendation for EC approval. Furthermore, the drug receives an additional year of market protection in the EU, thanks to its proven clinical benefit compared to existing therapies.   <\/p>\n\n<p class=\"wp-block-paragraph\">The EC approval follows the authorization by the U.S. Food and Drug Administration (FDA) in June, as well as the guidelines issued by the WHO. These recommend the administration of the medication twice a year as an additional PrEP option for HIV prevention. <\/p>\n\n<h2 class=\"wp-block-heading\">\u201cWith nearly 25,000 new HIV cases annually in the EU and the European Economic Area, <\/h2>\n\n<p class=\"wp-block-paragraph\">it is evident that existing preventive options are insufficient,\u201d commented Dr. Jean-Michel Molina. He is a professor of infectious diseases at Universit\u00e9 Paris Cit\u00e9 and head of the infectious diseases department at Saint-Louis and Lariboisi\u00e8re hospitals. \u201cThe new dosing regimen of <strong>Yeytuo<\/strong> and its high efficacy could become a long-awaited transformative option for HIV prevention in Europe. It will help us reduce new infections and make progress in the fight against the epidemic,\u201d Dr. Molina added.    <\/p>\n\n<p class=\"wp-block-paragraph\">As a reminder, in December 2024, <em>Science<\/em> magazine named <strong>lenacapavir<\/strong> the \u201cBreakthrough of the Year.\u201d<\/p>\n\n<p class=\"wp-block-paragraph\"><\/p>\n","protected":false},"excerpt":{"rendered":"<p>The European Commission has issued a marketing authorization for the first injectable HIV-1 capsid inhibitor \u2013 lenacapavir. It will be administered only twice a year, once every six months, announced the manufacturer Gilead. The drug will be marketed under the brand name Yeytuo. It is intended for pre-exposure prophylaxis (PrEP) to reduce the risk of [&hellip;]<\/p>\n","protected":false},"author":2,"featured_media":6447,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_jet_sm_ready_style":"","_jet_sm_style":"","_jet_sm_controls_values":"","_jet_sm_fonts_collection":"","_jet_sm_fonts_links":"","footnotes":""},"categories":[96],"tags":[],"class_list":["post-6446","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-news"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v28.6 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>EC gives green light to new HIV prevention therapy - Healthcare Magazine - \u0412\u043b\u0438\u044f\u043d\u0438\u0435 \u043e\u0442\u0432\u044a\u0434 \u043d\u043e\u0432\u0438\u043d\u0438\u0442\u0435<\/title>\n<meta name=\"description\" content=\"The EC has issued a marketing authorization for the first injectable HIV-1 capsid inhibitor \u2013 lenacapavir, which will be administered only twice a year.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/healthcaremagazine.bg\/en\/ec-gives-green-light-to-new-hiv-prevention-therapy\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"EC gives green light to new HIV prevention therapy - 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