FDA Awards Breakthrough Therapy Designation to Viela Bio Treatment for Rare Autoimmune Disease

The U.S. Food and Drug Administration granted Viela Bio Breakthrough Therapy designation for the company’s anti-CD19 monoclonal antibody inebilizumab, an experimental therapy for neuromyelitis optica spectrum disorder, a rare, life-threatening autoimmune disease affecting the central nervous system.

Neuromyelitis optica spectrum disorder (NMOSD), also known as Devic’s disease, is a condition in which the body’s immune system attacks healthy cells, most commonly in the optic nerves and spinal cord, resulting in severe damage. NMOSD may cause severe muscle weakness and paralysis, loss of vision, respiratory failure, problems with bowel and bladder function, and neuropathic pain. There is currently no cure or approved treatment for NMOSD.

Inebilizumab is a humanized monoclonal antibody that binds with high affinity to CD19, a protein expressed on a broad range of B cells, including antibody-secreting plasmablasts and some plasma cells. After binding to CD19, these cells are rapidly depleted from the circulation.

 “The Breakthrough Therapy designation for inebilizumab is based on results from the largest monotherapy study ever conducted in NMOSD,” said Jorn Drappa, chief medical officer and head of research and development at Viela Bio.

Breakthrough Therapy designation is designed to expedite the development and regulatory review of medicines intended to treat a serious condition that have shown encouraging early clinical results which may demonstrate substantial improvement on a clinically significant endpoint over available medicines. The designation for inebilizumab is based on data from the pivotal N-MOmentum study evaluating inebilizumab as a monotherapy.

The FDA and the European Medicines Agency previously granted Orphan Drug designation for inebilizumab for the treatment of patients with NMOSD.

Photo: Jorn Drappa, chief medical officer and head of research and development at Viela Bio

Author: Rare Daily Staff