Germany is the first European country to launch ublituximab, with further launches throughout Europe to follow
Only B-cell depleting therapy approved for relapsing multiple sclerosis (RMS) that is administered in a 1-hour infusion*, twice per year**
Launch follows ex-US commercialisation*** agreement with TG Therapeutics announced August 2023
Barcelona and Düsseldorf – 26 February 2024 – Neuraxpharm Group (Neuraxpharm), a leading European specialty pharmaceutical company focused on the treatment of central nervous system (CNS) disorders, today announces the first launch of BRIUMVI® (ublituximab) in Europe for the treatment of adult patients with relapsing multiple sclerosis (RMS) with active disease.
Germany is the first country in Europe to see the launch of ublituximab. This follows Neuraxpharm’s agreement with TG Therapeutics, announced in August 2023, to commercialise ublituximab outside the United States (US), Canada, Mexico and excluding certain Asian countries that have been previously partnered. Strengthening Neuraxpharm’s position as an innovation company specialising in CNS disorders, today’s launch is the first step in Neuraxpharm’s plans to make this product available to patients across Europe and beyond over the coming years.
Dr. Jörg-Thomas Dierks, Chief Executive Officer of Neuraxpharm, said: “Today’s launch is a significant breakthrough for people with RMS. The launch marks an important milestone for Neuraxpharm and reinforces our strategy to bring innovative treatments to our CNS patients. We are committed to making it available to as many patients as possible via our established network of neurology experts.”
* 95% of all ublituximab 1-hour infusions were completed in 1 hour.
** Following the induction dose, day 1 infusion is 150 mg over 4 hours; day 15 infusion is 450 mg over 1 hour; subsequent infusions are 450 mg over 1 hour, twice a year. Infusion duration may take longer if the infusion is interrupted or slowed.
*** Territories outside the United States, Canada, Mexico, and excluding certain Asian countries previously partnered.
For further information please contact:
Optimum Strategic Communications
Nick Bastin / Charlotte Hepburne-Scott / Elena Bates
Tel: +44 (0)203 882 9621
About ublituximab 150 mg/6 mL Injection for IV
In the EU, ublituximab is indicated for the treatment of adult patients with relapsing forms of multiple sclerosis (RMS) with active disease defined by clinical or imaging features.
Ublituximab is a novel monoclonal antibody that targets a unique epitope on CD20-expressing B-cells. Targeting CD20 using monoclonal antibodies has proven to be an important therapeutic approach for the management of autoimmune disorders, such as RMS.
Link to EMA-SmPC.