Solaris gains EU approval for NMOSD

28 August 2019

The European Commission (EC) has approved the extension of the current marketing authorization of Solaris (eculizumab) to include the treatment of neuromyelitis optica spectrum disorder (NMOSD) in adult patients who are anti-aquaporin-4 (AQP4) antibody-positive with a relapsing course of the disease, making it the first and only drug cleared for this condition in Europe.

NMOSD is an autoimmune disease of the central nervous system that mainly affects the optic nerves and spinal cord.

Marketed by US drugmaker Alexion Pharmaceuticals (Nasdaq: ALXN), Solaris was first approved in Europe in 2011 for the treatment of atypical hemolytic uremic syndrome. The drug is also cleared in Europe for paroxysmal nocturnal hemoglobinuria, as well as for certain patients with refractory generalized myasthenia gravis. The drug generated second-quarter 2019 sales of $980.8 million in the second quarter, up 9.2% compared to the prior-year period.

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