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SMC approve ofatumumab (Kesimpta) for active relapsing MS

Today the Scottish Medicines Consortium (SMC) approved ofatumumab (Kesimpta) as a new treatment option for relapsing MS in adults with active disease.

First self-administered B-cell targeting therapy

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

After initial guidance from a healthcare professional, ofatumumab can be self-injected at home. It’s injected once every 4 weeks.

The licence is based on the results of two Phase III clinical trials, called ASCLEPIOS, which compared ofatumumab to treatment with another existing disease modifying therapy (DMT), teriflunomide (also called Aubagio).

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

And it slowed down disability getting worse by up to 34%. This means that in the two trials, on average, people saw a drop of up to 34% in the risk of their disability getting worse. This was compared to people who took 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.

SMC is the organisation responsible for approving medicines for use on the NHS in Scotland. So today’s announcement applies to Scotland.

The National Institute for Health and Care Excellence (NICE), the body responsible for approving medicines for use in the NHS in England, approved ofatumumab for active relapsing MS in April 2021. This decision also applies to Wales. We’re expecting a decision in Northern Ireland sometime in 2021.

More treatment options for people in Scotland

Morna Simpkins, our Director in Scotland said: “It’s very welcome that ofatumumab has been approved for use on the NHS in Scotland. It increases the options for people to manage their condition and help prevent symptoms.

“Self-injecting ofatumumab could be particularly helpful for people who can't take time out of work to attend appointments or live far away from their nearest hospital.”

Great news for the MS community

Carla Callaghan is a communications officer and was diagnosed with relapsing remitting MS in 2013. She spoke about the importance of having different treatment options.

Carla said: “It's so important for me that there are a range of treatments available for MS. Over the past seven years I have been on three different DMTs.

“These treatments work differently for everyone and no one person with MS is the same, so it is absolutely crucial that there are a range of treatments that can be used.

“Without this range of treatments, the MS I have would definitely have progressed. My career is really important to me and without these treatments I wouldn't be able to do the job I love.”

Read more about getting treatment for MS