Ultomiris accepted for FDA Priority Review for gMG
21 December 2021 07:00 GMT Ultomiris regulatory submission accepted under FDA Priority Review in the US for adults with generalised myasthenia gravis Submission based on positive Phase III trial in which Ultomiris significantly improved functional activities as measured by Myasthenia Gravis-Activities of Daily Living Profile The supplemental Biologics License Application (sBLA) for Ultomiris (ravulizumab-cwvz) in adults with generalised myasthenia gravis (gMG) has been accepted for Priority Review by the US Food and Drug Administration (FDA). The FDA set a Prescription Drug User