FDA to Review Inebilizumab for Neuromyelitis Optica Spectrum Disorder

The Food and Drug Administration (FDA) has accepted for review the Biologics License Application (BLA) for inebilizumab (Viela Bio) for the treatment of patients with 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 BLA is supported by data from the pivotal N-MOmentum trial that evaluated the efficacy and safety of inebilizumab in 231 adult patients with NMOSD, including those with and without AQP4-IgG antibodies. Patients were randomized to receive 2 intravenous (IV) doses of inebilizumab monotherapy or placebo; 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 demonstrated a 77% reduction in the risk of developing an NMOSD attack with inebilizumab when compared with placebo in AQP4-IgG seropositive patients after 28 weeks (Hazard Ratio [HR]: 0.227; P <.0001). Similarly, a 73% reduction was observed in the total inebilizumab-treated patient population (HR: 0.272; P< .0001).

Additionally, inebilizumab demonstrated statistically significant benefits in key secondary end points vs placebo, including reduction in worsening from baseline in Expanded Disability Status Scale (EDSS) scores (15.5% vs 33.9%, respectively; P =.0049); reduction in NMOSD-related hospitalizations (10/174 patients vs 8/56 patients, respectively; P =.01; rate ratio: 0.286); and reduction in frequency of cumulative total active MRI lesions (79/174 patients vs 32/56 patients, respectively; P =.0034; rate ratio: 0.566).

Regarding safety, inebilizumab showed a favorable profile that was similar to placebo; rates of serious and/or ≥Grade 3 severity adverse events were also similar in the inebilizumab (10.3%) and placebo groups (14.3%).

“The acceptance of our first BLA filing for review represents a huge milestone for inebilizumab and another important step in delivering this novel therapy to patients in need,” said Jorn Drappa, MD, PhD, Chief Medical Officer and Head of R&D at Viela Bio. “We believe that inebilizumab can play a critical role in reducing the risk of developing an NMOSD attack, thereby contributing to the health of patients with this devastating and debilitating disease. We look forward to working closely with the FDA to move this therapy toward approval.”

For more information visit Vielabio.com.