Posted by Michael Wonder on 23 Feb 2019
FDA grants priority review and accepts sBLA of Soliris (eculizumab) as a treatment for patients with neuromyelitis optica spectrum disorder
22 February 2019 - FDA sets action date of 28 June 2019.
Alexion Pharmaceuticals today announced that the U.S. FDA has accepted for review a supplemental Biologics License Application (sBLA) for the use of Soliris (eculizumab), the company’s first C5 complement inhibitor, as a treatment for patients with neuromyelitis optica spectrum disorder who have anti-aquaporin-4 (AQP4) auto antibodies. The FDA granted priority review and set a Prescription Drug User Fee Act action date of 28 June 2019.
The application is supported by comprehensive data from the successful PREVENT study in patients with anti-AQP4 auto antibody-positive NMOSD.
