Posted by Michael Wonder on 21 Apr 2019
Viela Bio receives U.S. FDA breakthrough therapy designation for inebilizumab for treatment of neuromyelitis optica spectrum disorder
18 April 2019 - Designation based on positive primary analysis of pivotal study, N-MOmentum.
Viela Bio today announced that the U.S. FDA has granted breakthrough therapy designation for the Company’s anti-CD19 monoclonal antibody inebilizumab, an investigational monotherapy for neuromyelitis optica spectrum disorder (NMOSD).
NMOSD is a rare, life-threatening autoimmune disease affecting the central nervous system.
