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AstraZeneca’s Ultomiris Nears EU Green Light For NMOSD

After Positive CHMP Opinion

03 Apr 2023

• By Ayisha Sharma

The UK major’s long-acting C5 inhibitor is nearing EU approval for the debilitating rare disease as the company gears up for emerging competition and loss of exclusivity for its older drug Soliris.

Set of traffic lights against a bright blue sky, green light illuminated — Sales Of Ultomiris Are Growing As The Soliris Franchise Declines • Source: Shutterstock

AstraZeneca PLC’s Ultomiris has won a thumbs up from the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) for neuromyelitis optica spectrum disorder (NMOSD) as part of a broader strategy aimed at maintaining sales despite emerging competition and loss of exclusivity for predecessor drug Soliris.

The CHMP has issued a positive opinion on Ultomiris (ravulizumab) for anti-aquaporin-4 (AQP4) antibody positive (Ab+) NMOSD based on data...