AstraZeneca’ Soliris (eculizumab) Receives the NMPA’s Approval for the Treatment of Adults with Neuromyelitis Optica Spectrum Disorder
Shots:
- The NMPA has approved Soliris for adult patients with NMOSD who are anti-aquaporin-4 (AQP4) Ab+. The approval was based on the P-III trial (PREVENT) evaluating Soliris in a ratio (2:1) in 143 patients across North America, Argentina, the EU & Asia
- The trial met the 1EPs of prolonging the time to first adjudicated relapse & reducing the risk of relapse, 98% vs 63% were relapse-free at 48wks. (relative risk reduction, 94.2%), 96% vs 45% remained relapse-free at 144wks. The safety & tolerability profiles were consistent throughout both the primary treatment period & open-label extension
- Soliris was available in China for adults & children with PNH, aHUS as well as adults with gMG. The therapy was also approved for multiple indications in many countries globally
Ref: AstraZeneca | Image: AstraZeneca
Related News:- AstraZeneca’ Soliris Receives the MHLW Approval for Paediatric Patients with Generalised Myasthenia Gravis
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Neha is a Senior Editor at PharmaShots. She is passionate and very enthusiastic about recent updates and developments in the life sciences and pharma industry. She covers Biopharma, MedTech, and Digital health segments along with different reports at PharmaShots. She can be contacted at connect@pharmashots.com.
