Source Pharmaweb.com: Novartis receives positive CHMP opinion for Kesimpta® (ofatumumab), a self-administered treatment for adult patients with relapsing multiple sclerosis with active disease.
• CHMP opinion based on two Phase III ASCLEPIOS studies that met clinical and MRI endpoints, demonstrating a significant reduction in the number of relapses vs. teriflunomide, evaluated as the annualized relapse rate[i]
• Relapsing forms of multiple sclerosis (RMS) is the most common form of MS, with around 85% of people in the UK considered to have relapsing-remitting MS at the point of diagnosis[ii]
• If approved, ofatumumab will be the first and only self-administered, targeted B-cell therapy to slow disease activity in patients living with RMS1
• Self-administration at home gives RMS patients more flexibility and reduces the burden on patients, HCPs, and the NHS as it faces capacity challenges in light of COVID-19[iii
Novartis today 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 adult patients with relapsing forms of multiple sclerosis (RMS) with active disease, defined by clinical or imaging features. If approved, ofatumumab 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.