Ofatumumab (Kesimpta) approved for relapsing MS


19 July 2021

Kesimpta (ofatumumab) has been approved by NICE (National Institute for Health and Care Excellence) and the Scottish Medicines Consortium (SMC) for people with active relapsing remitting multiple sclerosis.

In England and Wales, NICE approved Kesimpta (ofatumumab) in April 2021 as a treatment for people with active relapsing remitting multiple sclerosis. NICE has recommended that Kesimpta (ofatumumab) can be prescribed for people who are having relapses or have MRI evidence of MS activity. 

In Scotland, the SMC approved Kesimpta (ofatumumab) in July 2021 as a treatment for people with relapsing remitting MS who are having relapses or have MRI evidence of MS activity. In Northern Ireland, the Department of Health reviews NICE guidance for NHS use.

The approval of Kesimpta (ofatumumab) increases the choices for people with relapsing MS. An expanding range of drugs, working in different ways and with different benefits and risks, means more people can find the treatment that is best for them. Kesimpta (ofatumumab) offers access to an effective treatment which doesn't require regular hospital visits.

I am really pleased with NICE's decision to recommend ofatumumab and was happy to take part in the appraisal. Ofatumumab has worked well for me so it's great that it will be added to the treatment options for other people with relapsing remitting MS. The injections are easy to do at home, leaving me free to carry on with my life in between.

Emma, person with MS

About Kesimpta

Kesimpta (ofatumumab) is self-injected under the skin. The first three injections are taken weekly, followed by injections once a month.

In clinical trials for relapsing remitting, Kesimpta reduced the risk of relapse by 50-59% compared to Aubagio (teriflunomide), reduced disability progression and the number of lesions seen on MRI scans.

Ofatumumab is a monoclonal antibody, a type of drug developed to attack specific targets in the immune system. Ofatumumab binds to a marker (CD20) on the surface of B cells, a type of white blood cell (lymphocyte) which is thought to be involved when the immune system attacks the myelin coating of nerves. Targeted B cells are destroyed. Ofatumumab works in similar way to Ocrevus (ocrelizumab).

In clinical trials, the most frequent side effects were injection related reactions. Most of these were mild to moderate, cleared up the same or following day and were associated with the first ofatumumab injection; they were less frequent with subsequent injections. Other side effects that occurred in at least 10% of those taking ofatumumab were head colds, headache, chest infections and urinary tract infections.

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