New Indication alert: EC approves AstraZeneca’s Ultomiris® (ravulizumab) for NMOSD

May 10, 2023

AstraZeneca announced that the European Commission has approved its Ultomiris® (ravulizumab) for an additional indication, the treatment of adults with anti-aquaporin-4 antibody-positive neuromyelitis optica spectrum disorder (NMOSD).  According to AstraZeneca, Ultomiris® is the first and only long-acting C5 complement inhibitor treatment for the above form of NMOSD in the EU, and EU is the first region in which this new indication has been approved.

This follows the positive opinion of the CHMP in April 2023 based on results from the CHAMPION-NMOSD Phase III trial.  Ultomiris® was previously approved in the US, EU and JP for the treatment of certain myasthenia gravis, paroxysmal nocturnal haemoglobinuria (PNH), atypical haemolytic uraemic syndrome to inhibit complement-mediated thrombotic microangiopathy.

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