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NICE approve Ofatumumab (Kesimpta) for active relapsing MS

Today the National Institute for Health and Care Excellence (NICE) approved ofatumumab (Kesimpta) as a new treatment option for relapsing MS in adults with active disease.

This follows on from the decision by the Medicines and Healthcare products Regulatory Agency (MHRA), and European Commission (EC).

Ofatumumab is a disease modifying therapy (DMT) which works by targeting a type of immune cell called a B cell.

First self-administered B-cell targeting therapy

Ofatumumab is the first self-administered B-cell targeting therapy to be licensed in the UK.

After initial guidance from a healthcare professional, ofatumumab can be self-injected at home. The licence is based on the results of two Phase III clinical trials, called ASCLEPIOS, which compared ofatumumab to treatment with another existing DMT, teriflunomide (also called Aubagio).

Ofatumumab demonstrated a significant reduction in the number of relapses as compared to teriflunomide.

Who will be able to access ofatumumab?

Ofatumumab has been approved for adults with active relapsing MS. Active disease is defined by MRI scans that identify inflammation or new or enlarging lesions.

The NICE decision applies to England. NHS England has 3 months to make treatment available following a decision, meaning the drug should be available to people living in England by July 2021.

NICE decisions will be checked by the Governments in Wales and Northern Ireland but are usually adopted.

The Scottish Medicine Consortium (SMC) are expected to publish a decision on recommending ofatumumab on the NHS in Scotland this summer (2021).

Making life easier for people who can't attend appointments

Fredi Cavander-Attwood, our Policy Manager says:

“People with MS often tell us about the convenience of being able to have a DMT at home instead of in hospital. Self injecting ofatumumab could be particularly helpful for people who can't take time out of work to attend appointments."

We updated this news story on Tuesday 20 April to reflect the NICE decision.