Alexion’s Phase III Data Position Ultomiris For Expansion Into Myasthenia Gravis
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.
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Two European companies - the Belgian-Dutch biotech Argenx and Calliditas of Sweden - are going it alone to commercialize their just-approved rare disease therapies in the US.
Argenx's efgartigimod could very soon become the first anti-FcRn agent to get approval for generalized myasthenia gravis but UCB’s rival therapy rozanolixizumab for the rare muscular disease is nearly ready to be filed with regulators.
AstraZeneca is discontinuing a Phase III trial of the long-acting complement inhibitor it gained via its Alexion acquisition in amyotrophic lateral sclerosis because of lack of efficacy in an interim analysis. Interest is now turning to antisense and cell therapy candidates from other companies that are in late-stage development for the condition.