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MARAC Statement: Crizanlizumab (Adakveo)
July 7, 2023 – SCDAA’s Medical and Research Advisory Committee (MARAC) notes that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) recommended on May 26, 2023, that the conditional marketing authorization for crizanlizumab (Adakveo) be revoked. The EMA stated that this revocation was triggered by the findings of the Novartis STAND multinational clinical trial showing no significant benefit of crizanlizumab over placebo in reducing pain or hospitalizations. Novartis reports that there were no safety problems in STAND. Abstract PB2512 submitted to the 2023 European Hematology Association reports no new safety issues in Novartis’ post-marketing surveillance of over 5,000 patient-treatment-years.
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