Alexion’s Soliris (eculizumab) Receives FDA’s Approval for Anti-Aquaporin-4 Antibody Positive Patients with Neuromyelitis Optica Spectrum Disorder

Alexion’s Soliris (eculizumab) Receives FDA’s Approval for Anti-Aquaporin-4 Antibody Positive Patients with Neuromyelitis Optica Spectrum Disorder

Shots:

  • The approval is based on P-III PREVENT study results assessing Soliris vs PBO in patients with neuromyelitis optica spectrum disorder (NMOSD) who are anti-aquaporin-4 (AQP4) antibody positive
  • The P-III PREVENT study results: @48wks. & @144wks. relapse free patients (98% & 96% vs 63% & 45%); relapse free patients without receiving IST @144wks. (100% vs 20%)
  • Soliris is a complement inhibitor, inhibiting the C5 protein in a complement cascade, approved in the US, EU & Japan for PNH & aHUS and is under EMA & MHLW’s review for NMOSD

Click here to read full press release/ article | Ref: Alexion | Image: The Valley Breeze