EU regulator recommends revoking authorisation for Novartis' sickle cell drug

[May 27, 2023]  (Reuters) -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.

The company's logo is seen at the new cell and gene therapy factory of Swiss drugmaker Novartis in Stein, Switzerland, November 28, 2019. REUTERS/Arnd Wiegmann/File Photo

(Reporting by Eva Mathews in Bengaluru; Editing by Shounak Dasgupta)

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