Viela planning BLA submission for inebilizumab in rare CNS disorder

Viela Bio Inc. (Gaithersburg, Md.) said it will submit a BLA to FDA this half for inebilizumab (MEDI-551) to treat neuromyelitis optica spectrum disorder (NMOSD) after the compound met the primary endpoint in the Phase II/III N-MOmentum trial in the indication. The company said worldwide regulatory submissions will quickly follow.

There are no approved therapies for NMOSD, a rare complement-mediated disorder of the CNS characterized by inflammatory lesions in the optic nerves and spinal cord...