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

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


Bengaluru: The European Medicines Company (EMA) mentioned on Friday it had really helpful revoking advertising authorisation for Novartissickle cell illness drug Adakveo.

The advice follows a overview by EMA’s human medicines committee (CHMP) that concluded the advantages of the drug didn’t outweigh dangers, in keeping with the regulator.

Sickle cell illness is a genetic dysfunction wherein misshapen blood cells trigger strokes, organ harm, extreme ache and early loss of life.

CHMP’s overview checked out outcomes of a examine, which in contrast the effectiveness and security of Adakveo when put next with a placebo in sufferers aged 16 years and older. Whereas the examine didn’t increase new issues, it confirmed a better price of extreme and severe treatment-related unintended effects for Adakveo in contrast with a placebo, EMA mentioned.

  • Printed On Might 26, 2023 at 06:24 PM IST

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