US EditionEU Approves Gilead’s New Injection for Preventing HIV
The European Commission approved Yeytuo for pre-exposure prophylaxis with nearly 100% effectiveness in trials to reduce HIV transmission, which infects 1.3 million people annually.
- This month, the European Commission authorised Gilead Sciences to market Yeytuo, a twice-yearly lenacapavir injection, across the European Union's 27 member states and EEA countries after an accelerated review with added market protection.
- Clinical evidence and WHO backing prompted lenacapavir's nearly 100% effectiveness in trials last year and its recommendation as a PrEP option in July, addressing 1.3 million annual HIV infections.
- Under the rollout plan, Gilead Sciences and the Global Fund to Fight AIDS, Tuberculosis and Malaria will supply lenacapavir to two million people in low- and middle-income countries, providing two six-monthly injections that reduce health resource demands compared to daily oral PrEP and shorter-acting injectables like Apretude.
- Some US insurers are holding off coverage due to Yeztugo's high price, and CVS Health declined to cover it earlier this month; EU access depends on reimbursement talks with national health systems.
- Gilead Sciences is pursuing regulatory filings in Australia, Brazil, Canada, South Africa and Switzerland, with analysts predicting Yeytuo could become a $4.5 billion product.
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After the European Commission gave its green light to the treatment of the American laboratory Gilead, Fabrice Pilorgé, director of advocacy for Aids, feared difficult negotiations on the price, but hoped that access to the product would be opened before the beginning of 2027.
Yeytuo, the name given for Europe to this treatment developed by the American laboratory Gilead, requires only two annual injections.
European Commission approves the Yeytuo de Gilead, an innovative treatment with only two injections a year, offering new hope in HIV prevention The European Commission has given
Named "Yytuo" in Europe, this medicine required only two injections a year had already been approved in June in the United States.
The drug, which can be used for prevention, only needs to be administered twice a year, which is a big improvement over the daily pills currently used.
European Commission approves twice-yearly HIV injection lenacapavir, paving way for EU rollout - The Tribune
The European Commission approved a twice-yearly HIV prevention injection, lenacapavir (Yeytuo), following EMA recommendation, Euro News reported. 'The Commission's quick approval underscores the transformative potential of Yeytuo,' said Gilead's Dr Dietmar Berger. The jab is 100% effective and will replace daily pills for adults and adolescents in the EU.
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