Briumvi approved in Europe for active, relapsing forms of MS

The European Commission has approved Briumvi (ublituximab) for the treatment of adults with relapsing forms of multiple sclerosis (MS) who have active disease, as defined by clinical or imaging features.

The approval, which covers all member states in the European Union, as well as Iceland, Norway, and Liechtenstein, comes a few months after Briumvi received a positive opinion from a branch of the European Medicines Agency (EMA). The therapy, which is marketed by TG Therapeutics, was approved in the U.S. to treat relapsing MS late last year.

“We are very pleased that the European Commission has approved Briumvi for the treatment of adult patients with multiple sclerosis,” Michael Weiss, chairman and CEO of TG, said in a press release.

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According to Weiss, the therapy is expected to be available commercially for patients in Europe later this year.

Briumvi is an anti-CD20 therapy that works by destroying B-cells, a type of immune cell that plays a central role in the inflammatory attack that drives MS. Briumvi is the third anti-CD20 therapy to win approval for relapsing forms of MS in the U.S. and Europe, following Ocrevus (ocrelizumab) and Kesimpta (ofatumumab).

The medication is administered via infusions into the bloodstream. After a first infusion lasting four hours, it is given every six months via infusions that last about an hour. This is notably shorter than for Ocrevus and other infused anti-CD20 therapies, which require about two hours to deliver. Kesimpta is given by monthly under-the-skin injections.

The European Commission’s approval of Briumvi “brings us one step closer to our goal of providing MS patients in Europe with an alternative treatment option that can be delivered in a one-hour infusion every 6 months following the starting dose,” Weiss said.

The ULTIMATE clinical trials

Approvals of Briumvi in the U.S. and EU were based on data from the Phase 3 clinical trials ULTIMATE I (NCT03277261) and ULTIMATE II (NCT03277248), which tested Briumvi against an older approved MS therapy, Aubagio (teriflunomide), in more than 1,000 people with relapsing types of MS.

Results showed that, after two years, patients on Briumvi had lower relapse rates and significant reductions in lesions. Data also suggested that Briumvi outperformed Aubagio on measures of disability and quality of life.

TG also recently presented new data from the trials, highlighting that Briumvi can help reduce fatigue, at the Consortium of Multiple Sclerosis Centers (CMSC) annual meeting. The presentation was titled “Ublituximab is Associated With Significant Improvement in Fatigue: Results From ULTIMATE I and II.”

Fatigue is one of the most common and troublesome symptoms of MS. In the ULTIMATE trials, patients’ fatigue was scored using the Fatigue Impact Scale (FIS). This standardized measure scores fatigue from 0 to 160, with higher numbers indicating worse fatigue that causes more problems in day-to-day life. A change of at least nine points is considered clinically significant.

Here, researchers pooled fatigue data from the two ULTIMATE studies and analyzed them collectively. Of note, this was a post hoc analysis, meaning the analysis was designed and conducted after the trials were over and data were already available.

Results showed that, by the end of the two-year studies, the average FIS score had decreased by 9.1 points among patients given Briumvi, compared to 4.4 points for those on Aubagio, indicating a significantly greater improvement in fatigue.

Similar significant differences between the two therapies were seen at earlier timepoints, though the average improvements were smaller than the minimum clinically significant change for both medications.

FIS scores after two years

Overall, 69% of patients on Briumvi had improved or stable FIS scores after two years on treatment, compared with 61% of those on Aubagio — a statistically significant difference.

Further analyses showed Briumvi consistently outperformed Aubagio across subscales on the FIS, including the impact of fatigue on physical, cognitive, and social function, with the number of patients having improved or stable scores in the physical domain after two years being significantly greater than those on a placebo.

“Across all timepoints, improvement in FIS was observed in all domains (cognitive, physical, social) and was significant in the physical domain,” the researchers concluded.