Sobi and Apellis report positive opinion by EMA committee.
NORDIC BUSINESS REPORT-October 15, 2021-Sobi and Apellis report positive opinion by EMA committee
(C)2021 M2 COMMUNICATIONS http://www.m2.com
Biopharmaceutical companies Swedish Orphan Biovitrum AB (Sobi) (STO:SOBI) and Apellis Pharmaceuticals Inc (Nasdaq:APLS) announced on Friday a positive regulatory opinion for treatment of paroxysmal nocturnal haemoglobinuria (PNH).
Based on Phase 3 study findings, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending the marketing authorisation of Aspaveli (pegcetacoplan) for the treatment of adults with PNH who are anaemic after treatment with a C5 inhibitor for at least three months. It will now be referred to the European Commission for an approval decision.
PNH is a rare, chronic...
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