Genmab Announces European Marketing Authorization for Kesimpta® (ofatumumab) in Relapsing Multiple Sclerosis
Copenhagen, Denmark; March 30, 2021 – Genmab A/S (Nasdaq: GMAB) announced today that the European Commission (EC) has granted Novartis marketing authorization for the use of Kesimpta® (ofatumumab) in the treatment of relapsing forms of multiple sclerosis (RMS) in adults with active disease defined by clinical or imaging features. The EC approval follows a positive opinion issued for subcutaneous ofatumumab in RMS by the CHMP of the European Medicines Agency (EMA) in January 2021. Kesimpta, which is developed and marketed worldwide by Novartis under a license agreement between Genmab and Novartis Pharma AG, is the first B-cell therapy that can be self-administered once-monthly at home via the Sensoready® autoinjector pen.
“We are extremely pleased that Kesimpta is now approved in both Europe and in the U.S., providing RMS patients with a convenient, efficacious and safe treatment option as demonstrated in the study findings from the ASCLEPIOS trials. We are looking forward to the launch of Kesimpta in the various European markets,” said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab.
The approval was based on data from the Phase 3 ASCLEPIOS I and II trials, which investigated the efficacy and safety of monthly subcutaneous ofatumumab 20mg versus once daily oral teriflunomide 14mg in adults with RMS. The results from the ASCLEPIOS studies were published in the August 6, 2020 issue of The New England Journal of Medicine.
The primary endpoint of both studies was to demonstrate that ofatumumab is superior to teriflunomide in reducing the frequency of confirmed relapses as evaluated by the annualized relapse rate (ARR) in patients treated up to 30 months1,2. Secondary endpoints included time to disability progression confirmed at three and six months respectively, confirmed disability improvement at six months, gadolinium enhancing T1 lesions, number of new or enlarging T2 lesions, serum levels of neurofilament light chain (NfL), and rate of brain volume loss1,2. Safety and the pharmacokinetic properties of ofatumumab were also all measured throughout the treatment period1,2.
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1 ClinicalTrials.gov. Efficacy and Safety of Ofatumumab Compared to Teriflunomide in Patients With Relapsing Multiple Sclerosis (ASCLEPIOS I). https://clinicaltrials.gov/ct2/show/NCT02792218. Accessed January 2020.
Company Announcement no. 24