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EU regulator recommends revoking authorisation for Novartis’ sickle cell drug, ET HealthWorld


Bengaluru: The European Medicines Agency (EMA) said on Friday it had recommended revoking marketing authorisation for Novartissickle 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.

  • Published On May 26, 2023 at 06:24 PM IST

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