The clinical research director at the UCSF Multiple Sclerosis Center discussed the anticipated impact of the recent FDA approval of inebilizumab (Uplizna; Viela Bio) for NMOSD.
“NMOSD has been a difficult-to-treat neurologic condition, recognized over a century ago…and we haven’t had any treatments that have been proved or approved until very, very recently. Now we have 2 drugs with approval, so this is big news for our NMO patients.”
This month, the FDA approved Viela Bio’s intravenous agent inebilizumab for the treatment of neuromyelitis optica spectrum disorder (NMOSD) in adults who are anti-aquaporin-4 (AQP4) antibody positive. The decision was based on findings from the largest ever monotherapy study in this population—the N-Momentum study (NCT02200770)—which showed that the risk of NMOSD relapse was reduced by 77% in the treatment group compared with placebo.
The lead investigator for that trial, Bruce Cree, MD, PhD, MAS, clinical research director, UCSF Multiple Sclerosis Center, and professor of clinical neurology, UCSF Weill Institute for Neurosciences, told NeurologyLive that this approval, coupled with that of the first agent, eculizumab (Soliris; Alexion), marks a “transformative moment” for patients with NMOSD. Cree explained that comparatively, the treatment of multiple sclerosis (MS)—which now features more than 10 agents—was at a similar point just a short time ago.
In this interview, Cree offered his perspective on the approval and its impact on the NMOSD treatment landscape. Additionally, he shared his insight into his experiences with inebilizumab in its clinical development and elucidated the advantages it may offer patients and physicians.
FDA Approves New Therapy for Rare Disease Affecting Optic Nerve, Spinal Cord. News release. FDA. June 11, 2020. Accessed June 19, 2020. https://www.fda.gov/news-events/press-announcements/fda-approves-new-therapy-rare-disease-affecting-optic-nerve-spinal-cord