Novartis announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion and recommended granting marketing authorization of Kesimpta® (ofatumumab) for the treatment of relapsing forms of multiple sclerosis (RMS) in adults with active disease defined by clinical or imaging features. Kesimpta is a targeted, precisely dosed and delivered B-cell therapy that has shown superior efficacy with a similar safety profile compared with teriflunomide, a first-line treatment in MS. Kesimpta has the potential to become a first-choice treatment option for patients with RMS that can be self-administered once-monthly at home via the Sensoready® autoinjector pen. The CHMP opinion is based on results from the Phase III ASCLEPIOS I and II studies, in which Kesimpta demonstrated superiority versus teriflunomide in significantly reducing the annualized relapse rate (ARR, primary endpoint), 3-month confirmed disability progression (CDP), and the number of gadolinium-enhancing (Gd+) T1 and new or enlarging T2 lesions. Results from these two studies were published in the August 6, 2020 issue of TheNew England Journal of Medicine. A separate post hoc analysis demonstrated that Kesimpta may halt new disease activity in RMS patients, with nearly nine out of 10 patients treated with Kesimpta achieving no evidence of disease activity (NEDA-3) in their second year of treatment. The CHMP recommended approval for Kesimpta with an indication for the treatment of adult patients with RMS with active disease defined by clinical or imaging features. The European Commission will review the CHMP recommendation and deliver its final decision in approximately two months. Kesimpta is a targeted B-cell therapy that delivers superior efficacy with a similar safety and tolerability profile compared with teriflunomide, a first-line treatment in MS. CHMP opinion is based on two Phase III ASCLEPIOS studies that met the primary endpoints where Kesimpta showed a reduction of the annual relapses by over 50% versus teriflunomide and achieved more than 30% relative risk reduction of 3-month confirmed disability progression (CDP). In a post hoc analysis, nearly nine out of 10 patients treated with Kesimpta achieved no evidence of disease activity (NEDA-3) in their second year of treatment. If approved, Kesimpta will be the first and only self-administered, targeted B-cell therapy for patients with relapsing multiple sclerosis in Europe.