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  • Novartis receives positive CHMP opinion for Kesimp...

Novartis receives positive CHMP opinion for Kesimpta, a self-administered treatment for adult patients with relapsing multiple sclerosis.

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Published:30th Jan 2021
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 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 pen. “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 possible,” 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 outcomes, 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 disability.” “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 home,” 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 system. " 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 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 treatment.
Condition: Multiple Sclerosis
Type: drug

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