AstraZeneca's Ultomiris gets expanded approval in EU for rare nervous system disorder
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The European Commission (EC) approved AstraZeneca's (NASDAQ:AZN) Ultomiris to treat adult patients with anti-aquaporin-4 (AQP4) antibody-positive (Ab+) neuromyelitis optica spectrum disorder (NMOSD).
The British pharma giant said Ultomiris is the first and only long-acting C5 complement inhibitor approved in the EU for treating this disease.
NMOSD is a central nervous system disorder which causes inflammation in nerves of the eye and spinal cord. The disorder occurs when the immune system reacts against its own cells.
The EC approval follows positive opinion by a committee of the European Medicines Agency (EMA) in March and was backed by data from a phase 3 trial called CHAMPION-NMOSD.
"Just four years since delivering the first approved NMOSD treatment to the EU, we are pleased to once again advance the treatment landscape with Ultomiris, which may eliminate relapses for people impacted by NMOSD," said Marc Dunoyer, CEO of Alexion, AstraZeneca's rare disease drugs unit.
Ultomiris is currently under review in the U.S. and Japan, among others, for treating NMOSD, according to AstraZeneca.