EMA committee recommends revocation of marketing authorisation for Novartis’ sickle cell disease medicine
EMA’s human medicines committee (CHMP) has recommended revoking the marketing authorisation for Adakveo (crizanlizumab), a medicine for preventing painful crises (called vaso-occlusive crises) in patients aged 16 years and older with sickle cell disease.
This follows a review by the CHMP, which concluded that the benefits of the medicine did not outweigh its risks. The review looked at results of the STAND study, which compared the effectiveness and safety of Adakveo with placebo (a dummy treatment) in patients who had previously had painful crises leading to a healthcare visit.
The study showed that Adakveo did not reduce the number of painful crises leading to a healthcare visit. Patients treated with Adakveo had on average 2.5 painful crises with a subsequent healthcare visit over the first year of treatment, compared with 2.3 crises in the placebo group.
In addition, the average number of crises requiring a healthcare visit or treatment at home was 4.7 with Adakveo compared with 3.9 with placebo.