Japan next to approve Ultomiris

26 May 2023

Ultomiris (ravulizumab) has been approved in Japan as the first and only long-acting C5 complement inhibitor for the treatment of adults with anti-aquaporin-4 (AQP4) antibody-positive (Ab+) neuromyelitis optica spectrum disorder (NMOSD).

Earlier this month, the European Commission approved Ultomiris, and regulatory submissions are currently under review with multiple health authorities elsewhere, including in the USA.

"An innovative long-acting treatment option that has the potential to eliminate relapses with convenient dosing every eight weeks"The drug has been developed by Alexion, a subsidiary of Anglo-Swedish pharma major AstraZeneca (LSE: AZN), as a follow-on from Soliris (eculizumab), its previously-approved treatment for NMOSD.

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