Research & Development
Sobi and Apellis report positive opinion by EMA committee
15 October 2021 -

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, life-threatening blood disorder characterised by the destruction of oxygen-carrying red blood cells through extravascular and intravascular haemolysis. Persistently low haemoglobin can result in frequent transfusions and debilitating symptoms such as severe fatigue, haemoglobinuria and difficulty breathing (dyspnea).

Aspaveli is the European trade name for pegcetacoplan, which is known as Empaveli in the United States where it is approved for the treatment of adults with PNH.

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