Novartis (NVS) receives positive CHMP opinion for Kesimpta, self-administered treatment for adult patients with relapsing multiple sclerosis

Novartis (NYSE: NVS) announced today 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 MS1. 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 pen3.

“In MS, one of the main goals of treatment is to achieve no evidence of disease activity as early on and for as long as possible4,” said Dr. Xavier Montalban, Multiple Sclerosis Centre of Catalonia (Cemcat), Vall d'Hebron University Hospital. “Knowing that early initiation of high-efficacy treatments can improve long-term outcomes5, it’s exciting to see that Kesimpta has the potential to halt new disease activity and help people to preserve neurological function and slow down the worsening of disability2.”

“The positive CHMP opinion for Kesimpta underscores its potential to provide people living with RMS in Europe with a new treatment that combines powerful efficacy with a favorable safety profile and can be taken at home1,3,” said Marie-France Tschudin, President, Novartis Pharmaceuticals. “By removing the need to go to an infusion center, Kesimpta has the capability to reduce the burden not only for patients, but also for physicians and the healthcare system6,7. Kesimpta is a testament to our commitment to reimagine medicine for the MS community and we will work closely with the regulatory authorities to ensure it is available for people living with MS as soon as possible.”


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 lesions1. Results from these two studies were published in the August 6, 2020 issue of The New 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 treatment2.


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.


In August 2020, the US Food and Drug Administration approved Kesimpta as an injection for subcutaneous use for the treatment of RMS, to include clinically isolated syndrome (CIS), relapsing-remitting disease, and active secondary progressive disease, in adults. On January 25, 2021, Kesimpta was approved in Canada for the treatment of relapsing remitting multiple sclerosis (RRMS).


*Brand name Kesimpta provisionally approved by EMA.

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