New Haven-based Alexion Pharmaceuticals Inc. is applying to U.S. and European regulators to market its drug Soliris to sufferers of a rare neuromuscular disease.
The biopharmaceutical company has submitted marketing applications to the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for Solaris, which has the potential to be used as a treatment of patients with a debilitating form of myasthenia gravis. The disease can cause debilitating conditions like difficulty walking, talking, swallowing and breathing, the company said Monday.
The European submission has been validated by the EMA, marking the beginning of the review process in Europe for this potential new use for Soliris. If approved, the drug would address a "significant unmet need for patients ... who have largely exhausted conventional therapy," the company said.
Soliris has received orphan drug designation for the treatment of patients with the disease in the U.S. and EU, but is not yet approved in any country for the treatment of patients.
Soliris also goes by the name eculizumab and was approved in the U.S. in 2007 to treat certain ultra-rare blood disorders.
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