Alexion Pharmaceuticals, Inc. ALXN today announced that Soliris®
(eculizumab), the company's first-in-class terminal complement
inhibitor, has received a positive opinion for orphan medicinal product
designation from the Committee for Orphan Medicinal Products (COMP) of
the European Medicines Agency (EMA) for the treatment of neuromyelitis
optica (NMO), a life-threatening, ultra-rare neurological disorder. The
positive opinion of the COMP has now been forwarded to the European
Commission for final approval and publication in the community register.
Soliris is not approved in any country for the treatment of patients
with NMO.
“We are pleased that the COMP has provided a positive opinion regarding
orphan medicinal product status for Soliris for the treatment of
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