Alexion Expands Indications for Long-Acting C5 Complement Inhibitor Ultomiris in Rare Autoimmune Disorder NMOSD

1. AstraZeneca's Ultomiris (ravulizumab-cwvz) receives FDA approval in the United States for the treatment of adults with neuromyelitis optica spectrum disorder (NMOSD).

2. Ultomiris is the first and only long-acting C5 complement inhibitor, providing immediate, complete, and sustained complement inhibition.

3. The drug demonstrated zero relapses in all 58 patients during the primary treatment period in the CHAMPION-NMOSD trial.

4. Ultomiris is already approved for various adult indications such as generalised myasthenia gravis (gMG), paroxysmal nocturnal haemoglobinuria (PNH), certain adults with atypical hemolytic uremic syndrome, and others.

5. The approval for NMOSD was based on the Phase III CHAMPIER-NMOSD trial results published in *Annals of Neurology*.

6. Marc Dunoyer, CEO of Alexion, AstraZeneca Rare Disease, highlighted Ultomiris as a transformative treatment option that offers patients the potential to live relapse-free with an eight-week dosing schedule.