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
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