Bengaluru: 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.
Paid Prime Membership on Primevideo.com