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

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

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

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Tuba Khan

Tuba Khan is Senior Editor at PharmaShots. She is curious, creative, and passionate about recent updates and innovation in the Life sciences industry. She covers Biopharma, MedTech, and Digital health segments. Tuba also has an experience of digital and social media marketing and runs the campaigns independently. She can be contacted on tuba@pharmashots.com

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