{"id":40238,"date":"2025-08-27T14:37:03","date_gmt":"2025-08-27T06:37:03","guid":{"rendered":"https:\/\/flcube.com\/?p=40238"},"modified":"2025-08-27T14:37:04","modified_gmt":"2025-08-27T06:37:04","slug":"gileads-yeytuo-gains-eu-marketing-authorization-for-twice%e2%80%91yearly-hiv%e2%80%911-prep","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=40238","title":{"rendered":"Gilead\u2019s Yeytuo Gains EU Marketing Authorization for Twice\u2011Yearly HIV\u20111 PrEP"},"content":{"rendered":"\n<p class=\"wp-block-paragraph\"><strong>European Commission Grant<\/strong> \u2013 On 26\u202fAug\u202f2025 <strong>Gilead Sciences<\/strong> (<a href=\"https:\/\/www.google.com\/finance\/quote\/GILD:NASDAQ\">NASDAQ: GILD<\/a>) announced that the <strong>European Commission (EC)<\/strong> has granted <strong>marketing authorization<\/strong> for its <strong>twice\u2011yearly injectable HIV\u20111 capsid inhibitor, Yeytuo (lenacapavir)<\/strong>.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Key Approval Details<\/strong><\/p>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><thead><tr><th>Item<\/th><th>Detail<\/th><\/tr><\/thead><tbody><tr><td><strong>Indication<\/strong><\/td><td>Pre\u2011exposure prophylaxis (PrEP) for sexually acquired HIV\u20111 in adults and adolescents at high risk<\/td><\/tr><tr><td><strong>Eligibility<\/strong><\/td><td>Adults and adolescents \u2265\u202f35\u202fkg<\/td><\/tr><tr><td><strong>Regulatory Scope<\/strong><\/td><td>EU\u201127, Norway, Iceland, Liechtenstein<\/td><\/tr><tr><td><strong>Administration<\/strong><\/td><td>Injectable, every 6\u202fmonths<\/td><\/tr><tr><td><strong>Drug Class<\/strong><\/td><td>Long\u2011acting HIV capsid inhibitor<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Why Yeytuo Is a Milestone<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>First and only twice\u2011yearly PrEP option<\/strong> approved in the EU and surrounding countries.<\/li>\n\n\n\n<li><strong>Convenient dosing<\/strong>\u2014only two injections per year, improving adherence relative to daily oral PrEP.<\/li>\n\n\n\n<li><strong>Global experience<\/strong> \u2013 Yeytuo builds on lenacapavir\u2019s earlier approvals for multi\u2011drug\u2011resistant HIV treatment (Sunlenca) in the U.S., EU, Japan, and other markets.<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Gilead\u2019s Strategic Position<\/strong><\/p>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><thead><tr><th>Aspect<\/th><th>Impact<\/th><\/tr><\/thead><tbody><tr><td><strong>Portfolio Expansion<\/strong><\/td><td>Adds a breakthrough prevention product to Gilead\u2019s HIV lineup.<\/td><\/tr><tr><td><strong>Market Leadership<\/strong><\/td><td>Positions Gilead as the sole provider of a twice\u2011yearly injectable PrEP in the EU, potentially capturing a sizable share of the prevention market.<\/td><\/tr><tr><td><strong>Patient Access<\/strong><\/td><td>Enables high\u2011risk populations to receive a less burdensome preventive regimen, potentially reducing new HIV infections.<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Future Outlook<\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Regulatory approvals in the EU are expected to drive global commercial rollout, with Gilead targeting launch in the United Kingdom and other major markets in the next 12\u201118\u202fmonths. The company plans to leverage its existing manufacturing and distribution networks to support the new indication.<a href=\"https:\/\/flcube.com\/\">-Fineline Info &amp; Tech<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>European Commission Grant \u2013 On 26\u202fAug\u202f2025 Gilead Sciences (NASDAQ: GILD) announced that the European Commission&#8230;<\/p>\n","protected":false},"author":1,"featured_media":40239,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"googlesitekit_rrm_CAownpewDA:productID":"","_jetpack_newsletter_access":"","_jetpack_dont_email_post_to_subs":false,"_jetpack_newsletter_tier_id":0,"_jetpack_memberships_contains_paywalled_content":false,"_jetpack_feature_clip_id":0,"_jetpack_memberships_contains_paid_content":false,"footnotes":"","jetpack_publicize_message":"","jetpack_publicize_feature_enabled":true,"jetpack_social_post_already_shared":true,"jetpack_social_options":{"image_generator_settings":{"template":"highway","default_image_id":0,"font":"","enabled":false},"version":2},"jetpack_post_was_ever_published":false},"categories":[7,11],"tags":[631,1025,15],"class_list":["post-40238","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-company","category-drug","tag-hiv-aids-care","tag-nasdaq-gild","tag-product-approvals"],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v27.5 (Yoast SEO v27.8) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>Gilead\u2019s Yeytuo Gains EU Marketing Authorization for Twice\u2011Yearly HIV\u20111 PrEP - Insight, China&#039;s Pharmaceutical Industry<\/title>\n<meta name=\"description\" content=\"Gilead Sciences (NASDAQ:\u202fGILD) announced on 26\u202fAug\u202f2025 that the European Commission approved its long\u2011acting HIV\u20111 capsid inhibitor, Yeytuo (lenacapavir), for pre\u2011exposure prophylaxis (PrEP). 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