Posted by Michael Wonder on 22 Dec 2021
Ultomiris regulatory submission accepted under FDA priority review in the US for adults with generalised myasthenia gravis
21 December 2021 - Submission based on positive Phase 3 trial in which Ultomiris significantly improved functional activities as measured by Myasthenia Gravis-Activities of Daily Living Profile.
The supplemental biologics license application for Ultomiris (ravulizumab-cwvz) in adults with generalised myasthenia gravis has been accepted for priority review by the US FDA.
