Apellis reports positive top-line results from phase III PEGASUS head-to-head study of pegcetacoplan compared to eculizumab for paroxysmal nocturnal hemoglobinuria.
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Apellis Pharmaceuticals, Inc. and Swedish Orphan Biovitrum AB (Sobi) announced that the European Commission (EC) has approved Aspaveli (pegcetacoplan), the first and only targeted C3 therapy, for the treatment of adults with paroxysmal nocturnal hemoglobinuria (PNH) who are anemic after treatment with a C5 inhibitor for at least three months.
Swedish Orphan Biovitrum AB (publ) (Sobi) and Apellis Pharmaceuticals, Inc. announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has adopted a positive opinion recommending the marketing authorisation of Aspaveli (pegcetacoplan) for the treatment of adults with paroxysmal nocturnal haemoglobinuria (PNH) who are anaemic 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.