Friday, June 02, 2023
TG Therapeutics, a publicly traded pharmaceutical company (NASDAQ: TGTX), has announced that it has received approval from the European Commission (EC) for its drug BRIUMVI® (ublituximab-xiiy) for the treatment of relapsing forms of multiple sclerosis (RMS) in adult patients with active disease based on clinical or imaging features.
Prior to this approval, BRIUMVI was granted approval by the U.S. Food and Drug Administration (FDA) on December 28, 2022, for the treatment of RMS in adults. It is the first and only anti-CD20 monoclonal antibody approved in the U.S. and now in the European Union (EU) for adult RMS patients. The drug can be administered through a one-hour infusion following the initial dose.
Michael S. Weiss, the Chairman and Chief Executive Officer of TG Therapeutics, expressed his satisfaction with the EC approval, as it brings the company closer to their goal of providing MS patients in Europe with an alternative treatment option. They aim to make BRIUMVI commercially available in Europe later this year.
The EC approval was based on data from the ULTIMATE I & II Phase 3 trials, which demonstrated the superior efficacy of BRIUMVI compared to teriflunomide in reducing the annualized relapse rate, the number of T1 Gd-enhancing lesions, and the number of new or enlarging T2 lesions. The results of these trials were published in The New England Journal of Medicine in August 2022.
With the EC approval, the centralized marketing authorization for BRIUMVI is now valid in all EU Member States, as well as Iceland, Norway, and Liechtenstein.
BRIUMVI is a novel monoclonal antibody that targets CD20-expressing B-cells. It is designed to efficiently deplete B-cells at low doses through a process known as glycoengineering, which involves removing certain sugar molecules from the antibody.
The drug is indicated for the treatment of adults with relapsing forms of multiple sclerosis, including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease.
Important safety information includes contraindications for patients with active HBV infection or a history of life-threatening infusion reactions to BRIUMVI. Infusion reactions and infections are among the potential risks associated with the drug, and caution is advised in cases of hepatitis B virus (HBV) reactivation and progressive multifocal leukoencephalopathy (PML). Vaccination guidelines and precautions are also provided.
Relapsing multiple sclerosis (RMS) is a chronic demyelinating disease of the central nervous system characterized by episodes of new or worsening signs or symptoms followed by periods of recovery. It is estimated that there are nearly 1 million people living with MS in the United States and over 2.3 million worldwide.
For more information about BRIUMVI, physicians, pharmacists, or healthcare professionals can visit the official website at www.briumvi.com. Additionally, TG Therapeutics offers the BRIUMVI Patient Support program to assist patients throughout their treatment journey, with more details available at www.briumvipatientsupport.com.