Novartis-Genmab's Kesimpta Gets EU Approval In Multiple Sclerosis

  • Novartis AG NVS said that Kesimpta (ofatumumab) had won European Union approval as the first and only self-administered, targeted B-cell therapy for adult patients with relapsing multiple sclerosis.
  • The company is developing and marketing the product under a license agreement with Genmab A/S GMAB.
  • The approval follows a positive opinion issued for subcutaneous ofatumumab by the CHMP of the European Medicines Agency in January this year.
  • Ofatumumab is a fully human CD20 monoclonal antibody. It is self-administered by a once-monthly injection, delivered subcutaneously.
  • Price Action: NVS shares closed 0.7% lower at $87.35 on Monday; GMAB shares are up 0.3% higher at $32.2 in premarket trading on the last check Tuesday.
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