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Latest From argenx N.V.
The European Medicines Agency has added seven new products to its list of medicines that are under review for potential EU marketing authorization.
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.
If Immuncore's tebentafusp is fast-tracked all the way through the centralized procedure at the EMA, it could be approved a few months earlier than it otherwise would be.
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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