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    Brief: Novartis Says CHMP Of European Medicines Agency (EMA) Adopted Positive Opinion Recommending Marketing Authorization For Cosentyx

    Picture of Novartis AG logoNovartis AG
    18/09/2026 16:00
    BRIEF-Novartis Says CHMP Of European Medicines Agency (EMA)  Adopted Positive Opinion Recommending Marketing Authorization For Cosentyx
    Sept 18 (Reuters) - NOVARTIS AG NOVN.S:
    • NOVARTIS ANNOUNCED TODAY THAT COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE (CHMP) OF EUROPEAN MEDICINES AGENCY (EMA) HAS ADOPTED A POSITIVE OPINION RECOMMENDING MARKETING AUTHORIZATION FOR COSENTYX(®)
    • NOVARTIS ANNOUNCED TODAY THAT COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE (CHMP) OF EUROPEAN MEDICINES AGENCY (EMA) HAS ADOPTED A POSITIVE OPINION RECOMMENDING MARKETING AUTHORIZATION FOR COSENTYX(®) (SECUKINUMAB) IN POLYMYALGIA RHEUMATICA (PMR).⁸
    • OPINION SUPPORTS COSENTYX USE FOR TREATMENT OF PMR IN ADULTS WHO HAVE HAD AN INADEQUATE RESPONSE TO STEROIDS OR WHO EXPERIENCE RELAPSE DURING STEROID TAPER
    • POSITIVE CHMP OPINION IS SUPPORTED BY RESULTS FROM PIVOTAL REPLENISH PHASE III TRIAL
    • FOLLOWING CHMP RECOMMENDATION FOR APPROVAL, EUROPEAN COMMISSION (EC) IS EXPECTED TO ISSUE A FINAL DECISION WITHIN APPROXIMATELY TWO MONTHS.
    Source text: ID:nGNE1fLwvK
    Further company coverage: NOVN.S

     (Gdansk Newsroom)
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