Alexion’s Soliris (eculizumab) Receives European Commission’s Approval for Neuromyelitis Optica Spectrum Disorder

Shots:

• The EC approval is based on P-III PREVENT study assessing Soliris vs PBO in patients with NMOSD who are anti-aquaporin-4 (AQP4) antibody-positive with a relapsing course of therapy and an undergoing extension study (ECU-NMO-302)
• The P-III PREVENT study results: met its 1EPs; @48wks. relapse-free patients (98% vs 63%); relapse-free patients without receiving immunosuppressive therapies (100% vs 60%); @144wks. sustained effects were observed
• Soliris is a complement inhibitor act by inhibiting C5 protein in the terminal part of the complement cascade and has received the US FDA’s approval for NMOSD in Jun’2019 with ODD in the US, EU and Japan and is under regulatory review in Japan

Click here to­ read full press release/ article | Ref: Alexion | Image: Display Builder