EU Regulator Seeks To Revoke Authorisation Of Novartis Sickle Cell Drug

The European Medicines Agency (EMA) said on Friday it had recommended revoking marketing authorisation for Novartis' sickle cell disease drug Adakveo.

The recommendation follows a review by EMA's human medicines committee (CHMP) that concluded the benefits of the drug did not outweigh risks, according to the regulator.

Sickle cell disease is a genetic disorder in which misshapen blood cells cause strokes, organ damage, severe pain and early death. CHMP's review looked at results of a study, which compared the effectiveness and safety of Adakveo when compared with a placebo in patients aged 16 years and older. 

While the study did not raise new concerns, it showed a higher rate of severe and serious treatment-related side effects for Adakveo compared with a placebo, EMA said.

(Reuters)