Europe – EU regulator recommends revoking approval for Novartis’ sickle cell disease drug

The EMA's human medicines committee concluded that the benefits of Adakveo did not outweigh its risks

The European Medicines Agency’s (EMA) human medicines committee has recommended revoking the conditional marketing authorisation for Novartis’ sickle cell disease (SCD) drug Adakveo (crizanlizumab).

The recommendation follows a review by the Committee for Medicinal Products for Human Use (CHMP) that concluded the benefits of the drug, which is indicated for preventing painful crises in SCD patients aged 16 years and older, did not outweigh its risks.

The CHMP’s review looked at results from the phase 3 STAND study, which compared the safety and efficacy of Adakveo with placebo…