Health Canada approves Uplizna for rare form of neuromyelitis optica spectrum disorder

Key Takeaways:

• The therapy demonstrated an acceptable safety profile and reduced the risk of NMOSD attacks with two infusions per year.
• A total of 87.6% of individuals remained relapse free 6 months after treatment.

Health Canada has approved Uplizna as a monotherapy for adults with neuromyelitis optica spectrum disorder who are anti-aquaporin-4 immunoglobulin G seropositive.

According to a release by Amgen, the approval was issued Dec. 15, and was based on results from the N-Momentum trial, in which treatment with Uplizna (inebilizumab-cdon, Horizon Therapeutics) demonstrated an acceptable safety profile while significantly reducing the risk of an NMOSD attack with only two infusions per year following administration of initial loading doses.

Further data cited in the release showed that 87.6% of individuals with AQP4-IgG+ remained relapse-free during a 6-month post-treatment interval.

Uplizna’s specific mechanism of action assists in the depletion of CD19+ B cells, which has been proven effective at halting inflammation, crucial as 90% of those who experience an initial NMOSD attack are likely to experience others within 5 years, per the release.

Uplizna was approved by the FDA in June 2020, by the Japanese Ministry of Health, Labor and Welfare in March 2021, by the European Commission in April 2022 and by the Brazilian Health Regulatory Agency in December 2022.

“Today's approval of Uplizna marks a significant milestone for adults living with NMOSD in Canada, bringing a new, targeted treatment option to those living with this devastating disease,” Horizon Canada GM Matt McCarthy said in the release. “We are committed to bringing new medicines to people living with rare and challenging diseases around the world, and today's announcement is an exciting milestone in that effort.”