CHMP favors Briumvi for approval to treat relapsing forms of MS in EU
Final decision on anti-CD20 antibody infusion therapy likely 'in coming months'
An arm of the European Medicines Agency favors the approval of Briumvi (ublituximab) to treat adults with active, relapsing forms of multiple sclerosis (MS) across the European Union (EU).
The Committee for Medicinal Products for Human Use (CHMP) opinion is based on data from twin Phase 3 trials, ULTIMATE I (NCT03277261) and ULTIMATE II (NCT03277248), that found the therapy significantly reduced the rate of relapses and prevented the formation of new lesions.
CHMP’s recommendation will now be examined by the European Commission, which is expected soon to make a final approval decision. Should Briumvi be approved, it will become available to eligible patients in all EU countries, as well as Iceland, Norway, and Liechtenstein.
Briumvi is given in an hourlong infusion every six months, after starting doses
“The positive recommendation … takes us one step closer to delivering Briumvi to patients and healthcare providers in Europe,” Michael Weiss, chairman and CEO of TG Therapeutics, Briumvi’s developer, said in a company news release. “We look forward to hearing a decision on the marketing authorization application by the European Commission in the coming months.”
Briumvi is an antibody-based medication that works by blocking the CD20 protein found on the surface of B-cells. These immune cells become overactive in MS and target the myelin sheath in the brain and spinal cord, causing inflammation and damage.
By blocking CD20, Briumvi lowers the number of B-cells in the bloodstream, which is expected to help reduce relapses and slow disease progression.
It works much like the other approved anti-CD20 antibody treatments, Ocrevus (ocrelizumab) and Kesimpta (ofatumumab). It is administered as a one-hour intravenous (into-the-vein) infusion every six months, after the two first doses.
The U.S. Food and Drug Administration approved Briumvi in December to treat adults with relapsing forms of MS: clinically isolated syndrome, relapsing-remitting MS, and active secondary progressive MS.
“I look forward to the potential approval of Briumvi and it being available to those in need of treatment alternatives in the EU,” said Hans-Peter Hartung, MD, PhD, a professor of neurology at Heinrich-Heine University Düsseldorf in Germany.
CHMP’s opinion was supported by ULTIMATE I and ULTIMATE II trial results, which compared Briumvi with Aubagio (teriflunomide), an approved oral medicine for relapsing MS, in a combined total of 1,094 adults.
Over two years of use, Briumvi significantly lowered annualized relapse rates by about 59% in ULTIMATE I and by 49% in ULTIMATE II, meeting each trial’s main goal. The number of inflammatory lesions and new or enlarging lesions also fell by at least 90% in both trials.
Post-hoc trial analyses, those conducted after the trials were completed, also demonstrated that more patients randomized to Briumvi experienced reductions in disability and improved quality of life measures.
According to Hartung, a steering committee member for ULTIMATE I and II, the trials’ findings “establish Briumvi as an effective MS treatment which can be administered in a one-hour infusion twice a year following the starting dose.”
Briumvi’s most common side effects are infusion-related reactions and respiratory tract infections. Other reported side effects include herpes virus-associated infections, pain, insomnia, and fatigue.