2023-06-07 12:23:14
On May 31, 2023, the European Commission (EC) approved ubituximab (Briumvi®) for the treatment of adult patients with relapsing forms of multiple sclerosis (RMS) with active disease on the recommendation of the European Medicines Agency (EMA).
In addition to ocrelizumab, ofatumumab and rituximab (off-label), another anti-CD-20 antibody will soon be available in the therapy of multiple sclerosis with the active substance ubituximab (market entry unknown). The antibody of the active substance ubituximab shows an altered glycosylation* on the surface. This change is said to be responsible for a particularly strong depleting (removing) effect on the CD-20 positive B cells of the immune system. According to reports from the EMA, ubituximab can reduce the rate of relapses and the number of acute inflammatory lesions. The most common side effects are injection-related reactions and infections.
The indication for the active ingredient, which is administered at a 150 mg concentration as an infusion every 24 weeks, is: “Ublituximab is indicated for the treatment of adult patients with relapsing forms of multiple sclerosis (RMS) with active disease, as defined by clinical findings or imaging.”
Ublituximab therapy should be initiated and monitored by specialist physicians experienced in the diagnosis and treatment of neurological disorders and who have access to appropriate medical care to treat severe reactions, such as serious infusion-related reactions.
Note: In the next issue of aktiv! (3-2023) we will report in more detail with an expert on the results of the pivotal studies.
Sources:
EC, European Commission 06/06/2023
EMA, European Medicines Agency- 31.03.2023
https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-briumvi_en.pdf (30.03.2023)
*Glycosylation: Describes a chemical modification of, for example, proteins with carbohydrates (sugars, also called saccharides such as glucose). The glycosylation can affect the stability of the protein, its degradation, functionality, binding properties, solubility, etc., among other things.
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