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Alexion’s Phase III Data Position Ultomiris For Expansion Into Myasthenia Gravis

 
• By Joseph Haas

As its acquisition by AstraZeneca moves toward closure, Alexion plans to file the Soliris follow-on for generalized myasthenia gravis in the US, EU and Japan. But potential competition awaits in the C5 inhibitor and FcRn antagonist classes.

Research scientist
Phase III data might put Alexion closer to adding myasthenia gravis to the Ultomiris label

Top-line Phase III data for Ultomiris in generalized myasthenia gravis (gMG) looked positive for Alexion Pharmaceuticals Inc. and its buyer, AstraZeneca PLC, but analysts wonder if another drug class might ultimately surpass complement 5 (C5) protein inhibitors in establishing a new standard of care.

Alexion reported on 16 July that its C5 inhibitor Ultomiris (ravulizumab) – a follow-on to Alexion’s rare disease blockbuster Soliris (eculizumab) – met statistical significance at 26 weeks of treatment...

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