CHMP recommends revocation of marketing authorisation for Adakveo in pain crises in sickle cell disease.- Novartis
The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended the revocation of the conditional marketing authorization (MA) for Adakveo (crizanlizumab), from Novartis, a once-a-month, humanized anti-P-selectin monoclonal antibody infusion indicated for the prevention of recurrent vaso?occlusive crises (pain crises) in sickle cell disease patients aged 16 years and older.
The STAND study findings are inconsistent with previous study results from SUSTAIN (NCT01895361), which demonstrated the superiority of crizanlizumab 5.0mg/ kg compared to placebo. Crizanlizumab’s efficacy has also been demonstrated through open-label study data. It is important to note that the STAND study results do not suggest new safety concerns with crizanlizumab. The overall safety profile of crizanlizumab remains consistent with the known profile of the commercially available 5.0mg/kg dose. No new patients will be treated with crizanlizumab in the European Union. For patients currently on crizanlizumab, healthcare professionals should discuss alternative treatment options with them.
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