NEW YORK - TG Therapeutics, Inc. (NASDAQ: NASDAQ:TGTX), a biopharmaceutical company focused on novel treatments for B-cell diseases, announced today the launch of BRIUMVI® (ublituximab-xiiy) in Europe by its partner Neuraxpharm Group, a specialty pharmaceutical company targeting central nervous system disorders.
The rollout began in Germany, with further European expansion planned. This marks the first European launch, triggering a $12.5 million milestone payment to TG Therapeutics under their commercialization agreement.
BRIUMVI is a monoclonal antibody for adults with relapsing forms of multiple sclerosis (RMS), characterized by active disease. It is already approved and available in the United States for various RMS conditions, including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease.
The European Commission and the UK's Medicines and Healthcare Products Regulatory Agency have also approved BRIUMVI for adult RMS patients with active disease, as defined by clinical or imaging features.
The therapy uses a novel approach to target CD20-expressing B-cells, a method that has shown significance in managing autoimmune disorders such as RMS. BRIUMVI's design omits certain sugar molecules, enhancing its B-cell depleting efficiency at lower doses.
Regarding the launch, Michael S. Weiss, Chairman and CEO of TG Therapeutics, expressed excitement for European RMS patients and anticipation for further updates as the launch progresses across Europe.
The European label for BRIUMVI includes contraindications for those with hypersensitivity to the substance or its excipients, severe active infections, severely immunocompromised states, and known active malignancies. Special warnings cover infusion-related reactions, potential infections, progressive multifocal leukoencephalopathy, hepatitis B virus reactivation, and vaccination precautions.
This development is based on a press release statement from TG Therapeutics, Inc.
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