FDA Clears Ravulizumab for Neuromyelitis Optica Spectrum Disorder

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The new indication in adults with AQP4 Ab+ NMOSD is based on positive results from a phase 3 trial that showed the long-acting C5 complement inhibitor protects against relapse.

The US Food and Drug Administration has expanded the indication for the long-acting C5 complement inhibitor, ravulizumab , to include adults with anti–aquaporin-4 antibody-positive neuromyelitis optica spectrum disorder .

In CHAMPION-NMOSD, the primary endpoint was met; none of the 58 patients taking ravulizumab had a relapse during treatment vs 20 patients who had a relapse in the placebo group of PREVENT (relapse risk reduction, 98.6%;NMOSD is a rare inflammatory syndrome of the central nervous system and can cause irreversible disability. The disorder affects an estimated 6000 adults in the United States.

 

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