AstraZeneca receives orphan drug designation for NMOSD therapy

AstraZeneca has announced that its new neuromyelitis optica spectrum disorder (NMOSD) therapy has been granted European orphan drug designation.

Developed by the company's global biologics research and development arm MedImmune, the new drug inebilizumab has received orphan designation from the European Medicines Agency for NMOSD, a rare and life-threatening autoimmune disease of the central nervous system.

Inebilizumab is currently in phase IIb clinical development and has shown potential as a treatment for the incurable disease, which can cause severe muscle weakness and paralysis, loss of vision, respiratory failure, problems with bowel and bladder function, and neuropathic pain.

It works by directly targeting and depleting cells that produce antibodies in the optic nerve and spinal cord that are responsible for driving the progression of the disease.

Orphan drug designation means AstraZeneca will receive development and market exclusivity incentives to accelerate the progress of the drug, due to its potential to benefit an underserved patient population.

Bing Yao, senior vice-president for research and development and head of MedImmune's respiratory, inflammation and autoimmunity innovative medicines unit, said: "The EMA's orphan designation for inebilizumab underscores the significant unmet need for patients with NMOSD, who currently have no options and face increasing damage and disability with each attack."

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