CHMP recommends marketing authorisation for Novartis’ Kesimpta
pharmafile | February 1, 2021 | News story | Sales and Marketing | Novartis, multiple sclerosis
The EMA’s Committee for Medicinal Products for Human Use (CHMP) has recommended the marketing authorisation of Novartis’ 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 and a similar safety profile compared with teriflunomide, a first-line treatment in MS. The drug has the potential to become a first-choice treatment option for patients with RMS that can be self-administered once-monthly at home, using the Sensoready autoinjector pen.
The CHMP’s opinion is based on results from the Phase III ASCLEPIOS I and II studies, in which Kesimpta demonstrated superiority compared with teriflunomide in significantly reducing the annualised relapse rate, three-month confirmed disability progression, and the number of gadolinium-enhancing T1 and new or enlarging T2 lesions.
A separate post hoc analysis demonstrated that the medicine may halt new disease activity in RMS patients, with nearly nine out of 10 patients treated with Kesimpta achieving no evidence of disease activity in their second year of treatment.
Dr Wallace Brownlee, Consultant Neurologist and Clinical Lead for the Multiple Sclerosis Service at the National Hospital for Neurology and Neurosurgery, said: “With relapsing forms of MS impacting the highest number of people living with MS in the UK, there is a need for a new treatment option that offers people with MS more flexibility and control in managing their disease outside of traditional hospital settings.
“Results from the ASCLEPIOS studies demonstrate that ofatumumab has a positive impact on reducing disease activity and slowing disability worsening in a convenient, once monthly formulation that can be given at home. Today’s news has the potential to offer the multiple sclerosis community, a much-needed self-administered treatment with proven benefits.”
Marie-France Tschudin, President of Novartis Pharmaceuticals, also commented: “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 favourable safety profile and can be taken at home.
“By removing the need to go to an infusion centre, Kesimpta has the capability to reduce the burden not only for patients, but also for physicians and the healthcare system. 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 European Commission will review the CHMP recommendation and deliver its final decision in approximately two months.
Darcy Jimenez
Related Content
Novartis shares new data about Fabhalta for IgAN treatment
Novartis has announced new results from a pre-specified interim analysis of its phase 3 APPLAUSE-IgAN …
Novartis shares new data for Zolgensma in children with SMA
Novartis has announced new data to continue the support of the clinical benefits of Zolgensma …
Novartis to acquire MorphoSys AG for €2.7bn
Novartis has announced that it has entered an agreement to acquire MorphoSys AG for €2.7bn, …
