BASEL (dpa-AFX) - Denmark-based Genmab A/S (GMXAY.PK) announced Tuesday that the European Commission has granted Novartis (NVS) marketing authorization to use Kesimpta (ofatumumab) to treat relapsing forms of multiple sclerosis or RMS in adults with active disease defined by clinical or imaging features.
Multiple sclerosis or MS is a chronic inflammatory disease of the central nervous system characterized by myelin destruction and axonal damage of the brain, optic nerves and spinal cord.
Kesimpta is the first and only B-cell therapy that can be self-administered for adult patients with relapsing multiple sclerosis approved in Europe. It can be used once-monthly at home via the Sensoready autoinjector pen.
Kesimpta is developed and marketed worldwide by Swiss drug major Novartis under a license agreement between Genmab and Novartis Pharma AG.
The EC approval follows a positive opinion issued for subcutaneous ofatumumab in RMS by the CHMP of the European Medicines Agency or EMA in January 2021.
The approval is based on Phase 3 ASCLEPIOS I and II studies. Kesimpta is already approved in the U.S.
Jan van de Winkel, Chief Executive Officer of Genmab, said the companies expects to launch Kesimpta in the various European markets.
Copyright RTT News/dpa-AFX
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