UK’s MHRA revokes authorisation for Novartis’ sickle cell drugWORLD NEWS
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.
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.