EMA panel recommends revocation of conditional marketing authorization for Novartis sickle cell disease medicine Adakveo

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.

"While we are disappointed by the recommendation to revoke the conditional MA for crizanlizumab in the European Union, we acknowledge that the STAND study did not meet one of the specific obligations of the conditional MA," the company stated.

"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. We continue to coordinate with health authorities globally. We maintain our confidence in crizanlizumab as an important treatment option when used to reduce the frequency of sickle cell pain crises, based on the overall body of evidence available to date," Novartis added.

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