Ofatumumab (OMB157) elicits a strong and fast reduction in the levels of circulating immune cells in people with relapsing forms of multiple sclerosis (MS), effectively helping to stop disease activity, according to new data from the Phase 2 APLIOS trial.
The medication was also found to be more effective than Aubagio (teriflunomide) at eliminating all signs of MS activity in a post-hoc analysis of the two Phase 3 ASCLEPIOS trials.
They further support ofatumumab, under regulatory review in the U.S. with a decision expected in June, as a potential treatment option for relapsing forms of MS.
Ofatumumab, co-developed by Genmab and Novartis, is a fully human antibody that specifically targets and blocks the activity of CD20, a protein receptor found on the surface of immune B-cells. These immune cells are thought to drive the damaging immune responses against myelin — the fatty substance that wraps around nerve fibers to ensure proper nerve cell communication — seen in MS patients.
By blocking CD20, ofatumumab is expected to lower the number of circulating B-cells and possibly limit their interactions with other immune cells, which are key in MS progression.
Requests for its approval are before both the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA), with an FDA decision likely to be announced in the coming weeks, and that of the EMA expected next year.
If approved, ofatumumab will be the first B-cell therapy that patients can give themselves at home using an autoinjector pen, called SensoReady.
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