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.
Crizanlizumab was given United States Food and Drug Administration (FDA) approval in November 2019 and remains on the market in the U.S. Americans with sickle cell disease are still receiving this treatment. MARAC urges the FDA to keep crizanlizumab available for use in the U.S. while it awaits more detailed examination of the data so that individuals with sickle cell disease can benefit from this treatment.
