Novartis receives EU approval for Kesimpta® (ofatumumab), the first and only self-administered, targeted B-cell therapy for adult patients with relapsing multiple sclerosis

• There are more than 1 million people living with multiple sclerosis (MS) in Europe¹, Kesimpta^® (ofatumumab) addresses the current unmet need for a high-efficacy disease-modifying therapy (DMT) that combines powerful efficacy and favorable safety profile with the flexibility of self-administration at home via the Sensoready^® autoinjector pen^2,3
• Approval based on two Phase III 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 progression²
• Kesimpta may halt new disease activity in relapsing forms of MS (RMS) patients, as shown in post hoc analysis, where nearly nine out of 10 patients treated with Kesimpta achieved no evidence of disease activity (NEDA-3) in their second year of treatment⁴
• EU approval follows recent approvals for Kesimpta including the US, Canada, Switzerland, Singapore, Australia and Japan

Basel, March 30, 2021 — Novartis announced today that the European Commission has approved 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 MS². Kesimpta is the first B-cell therapy that can be self-administered once-monthly at home via the Sensoready^® autoinjector pen and can be a first-choice treatment option for patients with RMS³.

“With more than 1 million people living with MS – an incurable condition so far – in Europe, it is encouraging to see that research continues to develop more treatments.  We welcome the approval from the European Medicines Agency that gives another treatment option for people living with RMS”, said Pedro Carrascal, President of the European Multiple Sclerosis Platform (EMSP).

“Slowing the worsening of disability is one of the main goals when managing RMS and evidence shows that early initiation of a high-efficacy treatment can improve long-term outcomes. Additionally, as RMS progresses, it can substantially increase overall healthcare costs as a result of increased disability,” said Haseeb Ahmad, Global Head of Value & Access, Novartis Pharmaceuticals. “Kesimpta’s powerful efficacy and favorable safety profile has the potential to become a first-choice treatment to help improve the quality of life of people living with MS, as well as having broader value in potentially reducing medical costs associated with infusion therapies. Kesimpta is a testament to our commitment to reimagine medicine and we remain dedicated to helping to improve the lives of people living with this disease.”