FDA and European Medicines Agency accept filing of licensing application for ofatumumab for treatment of relapsing forms of multiple sclerosis in adults

Novartis says approval is expected by 2nd quarter of 2021 in Europe, based on positive data from phase III ASCLEPIOS I and II studies which reported that this anti-CD20 monoclonal antibody demonstrated superiority over teriflunomide in reduction in number of confirmed relapses.