Ofatumumab (Kesimpta) gets UK licence for relapsing remitting MS

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

The MS Trust is very pleased that Kesimpta (ofatumumab) has been granted a UK licence. Kesimpta (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.

Kesimpta (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.

This is the first MS treatment to come through the MHRA process. When the UK was part of the EU, NICE and SMC referred instead to the European Medicines Agency (EMA). Once the EMA granted a marketing authorisation for a treatment, then NICE and SMC would evaluate the treatment for cost-effectiveness. 

Since January 2021, the MHRA is now the UK's medicines and medical devices regulator. EU law on drug products is no longer effect in the UK, except for Northern Ireland as part of the Northern Ireland Protocol. EMA marketing authorisations for drugs remain valid in Northern Ireland.

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.

• Kesimpta (ofatumumab) - our A-Z on Kesimpta, how it works and who can take it
• NICE appraisal for ofatumumab - the guidance document for England and Wales
• SMC appraisal for ofatumumab - the guidance document for Scotland
• Patient information leaflet for ofatumumab (EMC)
• Compare the different disease modifying drugs (DMDs) that are available to treat multiple sclerosis (MS)