Posted by Michael Wonder on 31 Mar 2021
Novartis receives EU approval for Kesimpta (ofatumumab), the first and only self-administered, targeted B-cell therapy for adult patients with relapsing multiple sclerosis
30 March 2021 - Approval based on two Phase 3 ASCLEPIOS studies that met primary endpoints where Kesimpta showed a reduction of annual relapses by over 50% versus teriflunomide, a first-line treatment in MS, and achieved more than 30% relative risk reduction of 3 month confirmed disability progression.
Novartis announced today that the European Commission has approved Kesimpta (ofatumumab) for the treatment of relapsing forms of multiple sclerosis in adults with active disease defined by clinical or imaging features.
