Can UCB Make Its Mark In Myasthenia Gravis?
Playing Catch-Up With Alexion And Argenx
The Belgian drugmaker has presented positive data on its two submission-ready generalized myasthenia gravis drugs zilucoplan and rozanolixizumab but analysts are concerned that their efficacy will not differentiate them sufficiently to challenge Vyvgart and Soliris/Ultomiris.
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The Belgian group’s US launch of Bimzelx could be delayed by up to a year after the FDA hit UCB with a complete response letter which states that "certain pre-approval inspection observations must be resolved” before the drug can get the green light for psoriasis.