European approval for Ultomiris for treating PNH

Ultomiris, the first and only long-acting C5 complement inhibitor administered every eight weeks, has been approved in Europe for treating adult patients with paroxysmal nocturnal haemoglobinuria (PNH).

PNH is an ultra-rare and severe disease that, when left untreated, may cause a wide range of debilitating symptoms and complications, including thrombosis.

The 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.

“More than a decade after Soliris was approved, Ultromiris (ravulizumab-cwvz) provides a major step forward in the treatment of PNH,” said Alexander Röth, Department of Haematology, West German Cancer Centre, University Hospital Essen.

“Now PNH patients can experience greater freedom in their lives with significantly fewer infusions per year without any compromise on efficacy or safety. This has been impressively demonstrated in the largest phase 3 program conducted in PNH so far.”

Ultomiris was approved in the US in December 2018 and in Japan in June 2019.

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