3 July 2019 - Ultomiris is the first approved, long-acting complement inhibitor for PNH, administered every other month, reducing the treatment burden for patients.

Alexion Pharmaceuticals today announced that the European Commission has approved Ultomiris (ravulizumab) — the first and only long-acting C5 complement inhibitor administered every eight weeks — for the treatment of adult patients with paroxysmal nocturnal haemoglobinuria (PNH) with haemolysis with clinical symptoms indicative of high disease activity, and also for adult patients who are clinically stable after having been treated with Soliris (eculizumab) for at least the past six months.

The European Commission approval is based on comprehensive results from two Phase 3 studies, which were recently published in Blood and represent the largest Phase 3 program ever conducted in PNH.

Read Alexion Pharmaceuticals press release