Apellis Pharmaceuticals, Inc. and Swedish Orphan Biovitrum AB (publ) announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has adopted a positive opinion recommending the marketing authorization of Aspaveli® (pegcetacoplan) for the treatment of adults with paroxysmal nocturnal hemoglobinuria (PNH) who are anemic after treatment with a C5 inhibitor for at least three months. The positive opinion from the CHMP is now referred to the European Commission for an approval decision.
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- Apellis Pharmaceuticals, Inc. and Swedish Orphan Biovitrum AB Receive Positive CHMP Opinion for Aspaveli® (pegcetacoplan) for the Treatment of PNH