Alexion Pharmaceuticals has revealed plans for initiating the CHAMPION-ALS clinical trial, a phase 3 study to evaluate ULTOMIRIS (ravulizumab) for the treatment of amyotrophic lateral sclerosis (ALS). The late-stage clinical trial, which will be held globally by the US pharma company for 50 weeks, will feature nearly 350 adults across a broad patient population. The […]
Ultomiris FDA approval : Alexion Pharmaceuticals has bagged approval from the US Food and Drug Administration (FDA) for Ultomiris (ravulizumab-cwvz) for the treatment of atypical hemolytic uremic syndrome (aHUS) in adults and pediatric (one month of age and older) patients. The approval is for the prevention of complement-mediated thrombotic microangiopathy (TMA) in such patient populations. […]
Ultomiris EU approval : Alexion Pharmaceuticals has secured approval from the European Commission (EC) for its C5 complement inhibitor Ultomiris (ravulizumab) for the treatment of paroxysmal nocturnal hemoglobinuria (PNH) in adults. The Ultomiris EU approval is for patients with PNH with hemolysis with clinical symptoms that indicate high disease activity, and also for adult patients […]
Alexion Pharmaceuticals has secured a significant milestone with the FDA granting priority review for its C5 complement inhibitor, SOLIRIS (eculizumab), as a treatment for neuromyelitis optica spectrum disorder (NMOSD) in patients who test positive for anti-aquaporin-4 (AQP4) autoantibodies. This critical approval comes as part of a supplemental Biologics License Application (sBLA), which has been accepted […]