European approval for Alexion’s Ultomiris in rare blood disease

Alexion has received marketing authorisation from the European Commission for its long-acting C5 complement inhibitor Ultomiris (ravulizumab) in the treatment of paroxysmal nocturnal hemoglobinuria (PNH) with haemolysis with high disease activity, as well as for adult patients who are clinically stable after having been treated with Soliris (eculizumab) for at least six months.

The decision was reached based on data drawn from two Phase 3 studies encompassing 440 participants.

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