UK’s MHRA revokes authorisation for Novartis’ sickle cell drug, ET HealthWorld


Bengaluru: Britain’s health regulator said on Wednesday it had revoked a conditional marketing authorisation for Novartis’ sickle cell disease drug, Adakveo.

The decision follows the Swiss drugmaker’s move to recall a batch of the drug after the Medicines and Healthcare products Regulatory Agency (MHRA) said it no longer considered the treatment’s benefits-to-risk balance favourable.

Sickle cell disease is a genetic disorder in which misshapen blood cells cause strokes, organ damage, severe pain and early death.

The European Medicines Agency (EMA) also revoked approval for the drug last year.

  • Published On Feb 21, 2024 at 06:22 PM IST

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