CHMP recommends variation of the indication for Aspaveli (pegcetacoplan) to include patients with paroxysmal nocturnal haemoglobinuria who have haemolytic anaemia and have not had previous treatment with a C5 inhibitor
The Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending a change to the terms of the marketing authorisation for the medicinal product Aspaveli
The marketing authorisation holder for this medicinal product is Swedish Orphan Biovitrum AB (publ) (SOBI).
The CHMP adopted an extension to the existing indication to include patients with paroxysmal nocturnal haemoglobinuria who have haemolytic anaemia and have not had previous treatment with a C5 inhibitor. For information, the full indication will therefore be as follows: Aspaveli is indicated as monotherapy in the treatment of adult patients with paroxysmal nocturnal haemoglobinuria (PNH) who are anaemic after treatment with a C5 inhibitor for at least 3 months have haemolytic anaemia.
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