AstraZeneca Ultomiris gets EMA backing for expanded use
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A committee of the European Medicines Agency (EMA) recommended the expanded approval of AstraZeneca's (NASDAQ:AZN) Ultomiris (ravulizumab) for treating adult patients with neuromyelitis optica spectrum disorder (NMOSD) who are anti-aquaporin 4 (AQP4) antibody-positive.
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 EMA's Committee for Medicinal Products for Human Use (CHMP) also issued a positive opinion for a new pharmaceutical form (solution for injection in a cartridge) linked with a new strength (245 mg) to be given via a new route, subcutaneously via an on-body injector.
The European Commission (EC), which generally follows the opinion of the CHMP, will now make a decision on the changes to the marketing authorization of the drug.