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Decision comes amid recommendation from agency’s Committee for Medicinal Products for Human Use.
Following the instructions of the European Commission (EC), Novartis has announced its removal of Adakveo (crizanlizumab) from the EU market. As a result of the agency’s Committee for Medicinal Products for Human Use (CHMP) recommending the action back in May, the EC has officially revoked conditional marketing authorization for the treatment. According to a company press release, the decision to rescind the conditional marketing authorization was based on a review of crizanlizumab under Article 20 of Regulation (EC) No 726/2004, initiated by the EC following the results of the phase III study, STAND (NCT03814746). The study reportedly did not emonstrate a statistically significant difference between crizanlizumab 5mg/kg or crizanlizumab 7.5mg/kg and placebo in annualized rates of vaso-occlusive crises leading to a healthcare visit over the first-year post randomization.
Currently, the medication remains in approval by the FDA for the reduction in frequency of vaso-occlusive crises in adults and pediatric patients aged 16 years or older with sickle cell disease.
Reference: European Commission (EC) adopts decision endorsing CHMP recommendation to revoke the conditional marketing authorization for Adakveo® (crizanlizumab). Novartis. August 4, 2023. Accessed August 7, 2023. https://www.novartis.com/news/european-commission-ec-adopts-decision-endorsing-chmp-recommendation-revoke-conditional-marketing-authorization-adakveo-crizanlizumab