FDA approval has been granted for Soliris injections to treat neuromyelitis optica spectrum disorder (NMOSD), an autoimmune disease of the central nervous system that affects the optic nerves and spinal cord.
NMOSD causes the body's immune system to attack healthy cells and proteins, most often in the optic nerves and spinal cord. Patients typically have attacks of optic neuritis, which causes eye pain and vision loss - approximately 50% of patients experience permanent visual impairment.
Dr Billy Dunn at FDA’s Center for Drug Evaluation and Research said: “This approval changes the landscape of therapy for patients with NMOSD.”
According to the National Institutes of Health, NMOSD affects 4,000 to 8,000 patients in the US. Women are at greater risk than men of developing the disease that affects more African Americans than Caucasians.
