Alexion Gets Positive CHMP Opinion for Soliris in Nervous-System Disorder
July 26 2019 - 9:26AM
Dow Jones News
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 colin.kellaher@wsj.com
(END) Dow Jones Newswires
July 26, 2019 09:11 ET (13:11 GMT)
Copyright (c) 2019 Dow Jones & Company, Inc.
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