AstraZeneca: green light for Ultomiris in NMOSD in US
(CercleFinance.com) - AstraZeneca announces that Ultomiris (ravulizumab-cwvz) has been approved in the US for the treatment of adult patients with neuromyelitis optica spectrum disorder (NMOSD), a rare and debilitating autoimmune disease affecting the central nervous system, including the spine and optic nerves.
Approval by the US FDA is based on positive results from a Phase III trial, published in Annals of Neurology.
Ultomiris met the primary endpoint of time to first relapse in the trial, as confirmed by an independent review committee.
No relapses were observed in Ultomiris patients with a median treatment duration of 73 weeks.
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