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Alexion Gets Positive Opinion From CHMP For SOLIRIS For Treatment Of NMOSD

Alexion Pharmaceuticals Inc. (ALXN) said that the European Medicines Agency or EMA Committee for Medicinal Products for Human Use or CHMP issued a positive opinion to extend the current marketing authorization of SOLIRIS or eculizumab to include the treatment of neuromyelitis optica spectrum disorder or NMOSD in adult patients who are anti-aquaporin-4 antibody positive with a relapsing course of the disease.

The European Commission will review the CHMP opinion and the final decision is anticipated within two months.

NMOSD is a rare, devastating, complement-mediated disorder of the central nervous system characterized by relapses, also referred to as attacks. Each attack results in stepwise accumulation of disability, including blindness and paralysis and sometimes premature death.

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