The Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to inebilizumab (Viela Bio), an investigational monotherapy for neuromyelitis optica spectrum disorder (NMOSD).
Inebilizumab, a humanized monoclonal antibody, is designed to bind with high affinity to CD19 resulting in the rapid depletion of B cells from the circulation, including autoantibody-secreting plasmablasts and CD19-expressing plasma cells. The FDA’s decision was based on preliminary data from the ongoing N-MOmentum study involving 231 NMOSD patients, including those with and without AQP4-IgG antibodies.
Patients were randomized to receive 2 intravenous doses of inebilizumab monotherapy or placebo and were followed for 6.5 months; patients were then placed into an open label extension in which they all received inebilizumab for 6 months. The primary outcome measure was time to onset of an adjudicated NMO/NMOSD attack.
Results from the primary analysis showed that treatment with inebilizumab was associated with a 77% reduction in the risk of developing an NMOSD attack when compared with placebo. In addition, compared with placebo, the inebilizumab arm demonstrated a reduction in worsening of disability. Additional details from the study will be presented at the 2019 American Academy of Neurology annual meeting.
“The Breakthrough Therapy Designation for inebilizumab is based on results from the largest monotherapy study ever conducted in NMOSD,” said Jorn Drappa, MD, PhD, Chief Medical Officer and Head of Research & Development at Viela Bio. “We continue our efforts to bring inebilizumab to patients suffering from this devastating disease for which there are currently no approved medicines.”
For more information visit Vielabio.com.