positive opinion for ravulizumab
Ravulizumab (Ultomiris®), the successor to eculizumab (Soliris®) by the manufacturer Alexion Pharmaceuticals, Inc., has been approved by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency. The CHMP issued a positive opinion for the treatment of adult patients with paroxysmal nocturnal hemoglobinuria (PNH) with Ultomiris® (ravulizumab).
Please note that this positive opinion from the CHMP does not yet mean that a marketing authorization has been granted, which requires a decision by the European Commission. The European Commission will review the CHMP recommendation and usually take its final decision within two months.