EU approval for Novartis’ treatment of relapsing forms of MS

EU approval for Novartis' treatment of relapsing forms of MS

The European Commission has approved Novartis’ Kesimpta® (ofatumumab) for the treatment of  (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.

This EU approval follows recent approvals for Kesimpta including the US, Canada, Switzerland, Singapore, Australia and Japan.

Pedro Carrascal, President of the European Multiple Sclerosis Platform (EMSP) said: “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 to people living with RMS.”

“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.”