UCB Moves Up Myasthenia Gravis Pipeline With Rozanolixizumab Win
Slips Into Second Place Behind Argenx's Efgartigimod
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.
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Keeping Track: Immunology Drives US FDA Action, With Approvals For AZ/Amgen’s Tezspire, Argenx’s Vyvgart, And New JAK Uses
The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker
The company's first-in-class FcRn antagonist, which has an FDA action date in December, is now being reviewed by the EMA and although the regulator rejected a request for an accelerated assessment of efgartigimod for generalized myasthenia gravis, commercial teams are being built up in Europe.
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.