TGA approves a new medication for MS: Ofatumumab

14 March, 2021
  • A new treatment for relapsing MS has been approved by the TGA in Australia
  • Ofatumumab will be marketed under the trade name Kesimpta®
  • This treatment is in the same class as the medication Ocrevus and reduces the number of certain B cells in the body

The Therapeutic Goods Administration (TGA) has approved ofatumumab (Kesimpta®) for the treatment of relapsing forms of MS.

The American Food and Drug Administration (FDA) approved ofatumumab mid 2020 for the treatment of relapsing MS, which includes clinically isolated syndrome (CIS), relapsing-remitting MS, and active secondary progressive MS.

Ofatumumab is an antibody against a protein called CD20 found on the surface of certain types of immune cells called B cells. It is similar to another MS medication ocrelizumab (Ocrevus), which also targets cells with CD20 protein on their surface. One novel feature of ofatumumab is that this treatment is given once per month, via injection using a special injector known as a Sensoready Pen (a patient-friendly autoinjector pen).

Clinical trials of ofatumumab showed that it was able to reduce the number of B cells in the body and  the formation of new brain lesions. There were two randomized, double-blind Phase 3 studies that compared the efficacy and safety of ofatumumab against aubagio (teriflunomide), an oral MS treatment. 1,881 people with either RRMS or active SPMS were enrolled in the trials.

The trials looked at the number of relapses, disability accumulation, and new lesions via magnetic resonance imaging (MRI). There was a reduction in risk of disability at 3 months and 6 months with ofatumumab compared with aubagio, as well as a reduction in the risk of developing new lesions. Taken together this suggests the ofatumumab is effective in treating people with relapsing forms of MS.

The approval of ofatumumab means that there are now 15 disease modifying therapies approved in Australia for MS, the majority for relapsing MS. However, everyone with MS responds differently to different medications and MS is a very varied disease. Thus it is very important that people with MS and their neurologists have access to a wide range of medications to ensure a greater chance of finding an appropriate treatment to achieve effective control of an individual’s MS.

It is important that people with MS discuss any new treatment options with their neurologist or health care professional as ofatumumab might not be suitable for everyone.

To view an updated factsheet on ofatumumab, please click here.

To view the public summary of ofatumumab from the TGA, please click here.

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