The decision comes after Amylyx in June requested a formal re-examination of the initial negative opinion adopted by the Committee for Medicinal Products for Human Use of the European Medicines Agency.
The Phase III STAND trial found no significant therapeutic benefit to Novartis’ Adakveo, pushing the European Commission to revoke its conditional authorization of the SCD treatment.
The approval on Wednesday by the European Commission, which follows a recent endorsement from the European Medicines Agency, comes about a month after the U.S. health regulator gave the drug Arexvy the green light.
The European Medicines Agency (EMA) is recommending Novavax’s COVID-19 vaccine carry a warning of the possibility of two types of heart inflammation, an added burden for a shot that has so far failed to win wide uptake.
The European Medicines Agency (EMA) is open to using next generation COVID-19 vaccines that target older offshoots of the Omicron variant this fall, an official said on Thursday, amid a rise in cases due to new Omicron subvariants.