Genmab A/S [NASDAQ: GMAB] disclosed Tuesday that its Kesimpta has been awarded EMA by EC for the cure of relapsing forms of multiple sclerosis (RMS) in grownups with an illness that is specified by medical or visualization features. The firm has received EMA from EC after the positive recommendation by the CHMP of the EMA for subcutaneous ofatumumab in RMS in January 2021.
Kesimpta is being created and commercialized all around the globe by Novartis under a licensing deal between Genmab and Novartis Pharma AG. Kesimpta is the first B-cell therapy that can be self-inoculated at home via the Sensoready autoinjector pen once a month.
The EMA which the firm has received for Kesimpta after the analysis of the data of Phase III ASCLEPIOS I and II studies. The studies have been carried out to assess the potency and safety of ofatumumab 20mg once a month against the regular oral teriflunomide 14mg in grownups with RMS.
CEO of Genmab commented that the firm is delighted to get the approval for Kesimpta in the US and Europe. This will provide a better cure to sufferers who have been living with the disease. The firm has also disclosed its plan to roll out Kesimpta in the different European marketplaces.