Patient Perspective on the Health Canada Approval of Inebilizumab for NMOSD: Sumaira Ahmed

WATCH TIME: 3 minutes

“I think this is a huge milestone for patients, caregivers, and clinicians in the Canadian community. I think this approval symbolizes hope for the future because now there will be options for patients to choose what therapy works best for them, give them the opportunity to live a higher quality of life. I think it's a huge beacon of hope and I'm very excited for the Canadian community to have options for therapies that are designed for their diseases."

In June 2020, the FDA approved inebilizumab (Uplizna; Horizon Therapeutics) for the treatment of patients with neuromyelitis optica spectrum disorder (NMOSD) who are anti-aquaporin-4 (AQP4) antibody positive, marking it the second approved therapy for patients with the condition.¹ The humanized, monoclonal antibody is designed to bind with high affinity to CD19 and deplete a broad range of B cells, including autoantibody-secreting plasmablasts and CD19-expressing plasma cells. It originally received breakthrough therapy designation from the FDA in April 2019 based on findings from the phase 2/3 N-MOmentum trial (NCT02200770).

Most recently, Health Canada granted approval of inebilizumab as an injection monotherapy for the treatment of adult patients with NMOSD, with findings from the N-MOmentum study also serving as the supportive data.² In the trial, 21 of 174 (21%) participants who received inebilizumab had an attack compared with 22 of 56 (39%) participants who received placebo (HR, 0.272; 95% CI, 0.150–0.496; P <.0001). Notably, 87.6% of patients in the AQP4-IgG+ group remained relapse-free during the 5-month period post-treatment.³

In a recent interview with NeurologyLive®, Sumaira Ahmed, the founder and executive director of the Sumaira Foundation, sat down to share her patient perspective on how the recent approval of inebilizumab in Canada impacts the choices available to patients, caregivers, and clinicians. She also talked about how the approval process for this therapy sets a precedent for other treatments in the pipeline, and how it might encourage patient participation in clinical trials. With the rarity of treatments for rare diseases, Ahmed spoke about how the accessibility of FDA-approved therapies in the US, and the potential in Canada, shape the experience of patients and their families.

REFERENCES
1. FDA Approves New Therapy for Rare Disease Affecting Optic Nerve, Spinal Cord. News release. FDA. June 11, 2020. Accessed January 26, 2024. https://www.fda.gov/news-events/press-announcements/fda-approves-new-therapy-rare-disease-affecting-optic-nerve-spinal-cord
2. Health Canada Approves UPLIZNA® (inebilizumab for injection) for the Treatment of Neuromyelitis Optica Spectrum Disorders (NMOSD). News Release. Horizon Therapeutics. Published January 16, 2024. Accessed January 26, 2024. https://www.newswire.ca/news-releases/health-canada-approves-uplizna-r-inebilizumab-for-injection-for-the-treatment-of-neuromyelitis-optica-spectrum-disorders-nmosd--885268847.html
3. Cree BAC, Bennett JL, Kim HJ, et al. Inebilizumab for the treatment of neuromyelitis optica spectrum disorder (N-MOmentum): a double-blind, randomised placebo-controlled phase 2/3 trial. Lancet. 2019;394(10206):1352-1363. doi:10.1016/S0140-6736(19)31817-3