Alexion drug receives FDA approval for rare autoimmune disease of spinal cord

Spinal Tech

Alexion Pharmaceuticals' Soliris received FDA approval for the treatment of neuromyelitis optica spectrum disorder in adult patients who test positive for the anti-aquaporin-4 antibody.

Three insights:

1. NMOSD is a rare autoimmune disease of the central nervous system that effects the spinal cord and optic nerves.

2. The immune system attacks healthy cells and proteins in the body, primarily in the spinal cord and optic nerves, which can lead to vision loss and paralysis of the arms or legs among other conditions.

3. A clinical study of 143 patients with NMOSD demonstrated that treatment with Soliris decreased the number of relapses by 94 percent over the course of the 48-week trial. It also cut the need for hospitalizations and treatment of acute attacks with corticosteroids and plasma exchange.

"Having an approved therapy for this condition is the culmination of extensive work we have engaged in with drug companies to expedite the development and approval of safe and effective treatments for patients with NMOSD, and we remain committed to these efforts for other rare diseases," said Billy Dunn, MD, director of the division of neurology products in the FDA's Center for Drug Evaluation and Research.

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