Alexion Gets Positive CHMP Opinion for Soliris in Nervous-System Disorder

By Colin Kellaher

Alexion Pharmaceuticals Inc. (ALXN) Friday said the European Medicines Agency's Committee for Medicinal Products for Human Use recommended extending approval of the company's Soliris to cover a rare disorder of the central nervous system.

The Boston biopharmaceutical company said the CHMP positive opinion covers Soliris for the treatment of neuromyelitis optica spectrum disorder in adults who are anti-aquaporin-4 antibody positive with a relapsing course of the disease.

Alexion said the rare condition, which attacks the central nervous system without warning, is characterized by relapses that result in the accumulation of disability, including blindness, paralysis and sometimes premature death.

Alexion said the European Commission will review the CHMP opinion, with a final decision expected within two months. The commission generally follows the CHMP's recommendations.

Soliris is already approved in the EU for adults with paroxysmal nocturnal hemoglobinuria and for adults and children with atypical hemolytic uremic syndrome.

Shares of Alexion, which closed Thursday at $118.03, rose about 3.4% in light premarket trading Friday.

Write to Colin Kellaher at [e-mail]

(END) Dow Jones Newswires

July 26, 2019 09:11 ET (13:11 GMT)

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