Novartis now bags UK license for Kesimpta

Novartis (NOVN: VX) today announced that the UK’s Medicines and Healthcare products Regulatory Agency (MHRA), alongside the recent European Commission, has granted a marketing authorization for the use 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.

Ofatumumab has the potential to become a recognized treatment option for eligible UK patients with RMS that can be self-administered, with initial guidance from an appropriately trained healthcare professional, once monthly at home via the Sensoready autoinjector pen, said the Swiss pharma giant, which has licensed the drug from Danish cancer specialist Genmab (Nasdaq: GMAB).

Ofatumumab is one of the first treatments to undergo the new regulatory process following the UK’s departure from the European Union. The final Marketing Authorization (MA) from the MHRA, brings eligible patients living with RMS a step closer to access Kesimpta in England, Scotland and Wales. Initial decisions on Kesimpta from the National Institute for Health and Care Excellence (NICE) and the Scottish Medicine Consortium (SMC) are expected to publish their final advice this year.