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Lék Kisunla od společnosti Eli Lilly na Alzheimerovu chorobu získal kladné stanovisko CHMP

Lék Kisunla (donanemab) od společnosti Eli Lilly (NYSE:LLY) na léčbu Alzheimerovy choroby získal kladné stanovisko Výboru pro humánní léčivé přípravky (CHMP) Evropské agentury pro léčivé přípravky, který doporučil tento lék pro léčbu časných symptomů Alzheimerovy choroby.

Očekává se, že Evropská komise přijme konečné regulační rozhodnutí o donanemabu v následujících měsících, a to na základě tohoto doporučení.

CHMP založil své kladné stanovisko především na údajích ze dvou klinických studií: TRAILBLAZER-ALZ 2 a TRAILBLAZER-ALZ 6. Tyto studie poskytly důkazy, které podpořily doporučení výboru ke schválení.

Pokud bude lék schválen Evropskou komisí, bude Kisunla k dispozici jako možnost léčby pro pacienty s časnými symptomy Alzheimerovy choroby ve všech členských státech Evropské unie.

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