Posted by Michael Wonder on 29 Jan 2021
Novartis receives positive CHMP opinion for Kesimpta (ofatumumab), a self-administered treatment for adult patients with relapsing multiple sclerosis
29 January 2021 - CHMP opinion is based on two Phase 3 ASCLEPIOS trials that met the primary outcomes 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.
Novartis announced today that the CHMP of the EMA has adopted a positive opinion and recommended granting marketing authorisation of Kesimpta (ofatumumab) for the treatment of relapsing forms of multiple sclerosis in adults with active disease defined by clinical or imaging features.
