Bangalore: European Medicines Agency (EMA) announced on Friday that it recommended revoking marketing authorizations for the following products: Novartis‘ sickle cell disease medicine Adakveo.
The recommendation follows a review by the EMA’s Committee on Medicinal Products for Human Use (CHMP) that concluded that the benefits of the drug did not outweigh the risks, the regulator said.
sickle cell disease It is a genetic disorder in which malformed blood cells cause stroke, organ damage, severe pain, and premature death.
The CHMP review looked at the results of studies comparing efficacy and safety. Adakveo When compared to placebo in patients aged 16 years and older. The study raised no new concerns, but showed a higher incidence of serious side effects associated with Adakveo treatment compared to placebo, EMA said.