Ofatumumab (Kesimpta) gets UK licence for relapsing remitting MS

13 April 2021

The MHRA (Medicines and Healthcare Products Regulatory Agency) has granted marketing authorisation for ofatumumab (Kesimpta) to treat relapsing remitting multiple sclerosis where people are having relapses or showing new lesions on MRI scans.

We are very pleased that ofatumumab has been granted a UK licence. Ofatumumab is an effective treatment which people take at home once a month and will be a useful alternative to other disease modifying drugs which require treatment in hospital clinics.

- David Martin, Chief Executive Officer, MS Trust

Ofatumumab will now need to be appraised by NICE and SMC to decide if it should be prescribed by the NHS in the UK. NICE has started the process and a decision is expected to be published before the end of April. SMC has also begun their appraisal with a decision expected later this year.

About ofatumumab

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 MS, ofatumumab reduced the risk of relapse by 50-59% compared to Aubagio, 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.