EC approval for Sobi’s PNH drug

8 May 2024

Swedish Orphan Biovitrum (STO: SOBI) has announced that the European Commission (EC) has approved an indication extension for Aspaveli (pegcetacoplan) to treat adults with paroxysmal nocturnal haemoglobinuria (PNH) who have hemolytic anemia.

Aspaveli is already approved in Europe for the treatment of adults with PNH who are anemic after treatment with a C5 inhibitor for at least three months.

"Today’s approval underscores the robust clinical data supporting Aspaveli 's efficacy and safety profile"It is now the first C3 inhibitor approved for first-line treatment of PNH in Europe, offering effective outcomes by improving haemoglobin and other clinical markers due to its unique mode of action.

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