At the second time of asking, AstraZeneca's Ultomiris gains US nod for NMOSD
2024-03-25
上市批准临床3期临床结果
AstraZeneca’s Ultomiris (ravulizumab-cwvz) gained approval from the FDA for the treatment of adults with AQP4 antibody-positive (Ab+) neuromyelitis optica spectrum disorder (NMOSD). The agency had rejected the long-acting C5 complement inhibitorC5 complement inhibitor in this indication last year, calling for modifications to the risk evaluation and mitigation strategy (REMS).
Specifically, the FDA requested changes to the REMS to further validate patients' meningococcal vaccination status or prophylactic administration of antibiotics prior to treatment.
AstraZeneca said Monday that approval of Ultomiris was based on findings from the Phase III CHAMPION-NMOSD trial. The study achieved its primary endpoint of time to first on-trial relapse, with no relapses observed among Ultomiris patients with a median treatment duration of 73 weeks.
Marc Dunoyer, CEO of the company’s Alexion unit, noted that Ultomiris “has the potential to eliminate relapses with a convenient dosing schedule every eight weeks.” The intravenous therapy is currently approved to treat AQP4 Ab+ NMOSD in the EU, Japan and Canada, with regulatory reviews ongoing in additional countries.
In addition, Ultomiris is authorised in the US for the treatment of: certain adults with generalised myasthenia gravis; certain adults and children with paroxysmal nocturnal haemoglobinuria; and certain adults and children with atypical haemolytic uraemic syndrome to inhibit complement-mediated thrombotic microangiopathy.
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