Horizon’s Uplizna (inebilizumab) Receives EC’s Approval for the Treatment of Neuromyelitis Optica Spectrum Disorder
Shots:
- The approval was based on the P-II/III (N-MOmemtum) trial evaluating Uplizna vs PBO in a ratio (3:1) in 230 patients (213 were AQP4-IgG seropositive & 17 were AQP4 IgG seronegative) with NMOSD across 25 countries
- The results showed a reduction in risk of an NMOSD attack with 2 infusions/yr., following the initial loading doses, 89% of AQP4-IgG+ patients remained relapse-free @6mos. post-treatment period & ≥83% remained attack-free @4yrs. & had a favorable safety profile
- The EC approval is valid in all EU Member States, Iceland, Liechtenstein & Norway. The company will work with local health authorities to provide access to patients to use Uplizna across the EU
Ref: Businesswire | Image: Horizon
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