London, UK, Barcelona, Spain and Düsseldorf, Germany – 5 December 2024 – Neuraxpharm Group (Neuraxpharm), a leading European specialty pharmaceutical company focused on the treatment of central nervous system (CNS) disorders, today announces that the National Institute for Health and Care Excellence (NICE) in the UK has issued a positive recommendation for the use of ublituximab (150 mg concentrate for solution for infusion) in the treatment of relapsing-remitting multiple sclerosis (RRMS).1
Ublituximab, developed by TG Therapeutics and licensed by Neuraxpharm ex-US, is a type of protein called a monoclonal antibody that selectively targets CD-20-expressing cells.2 It is the first and only anti-CD20 monoclonal antibody approved in the United States (US) and European Union (EU) for adult patients with RRMS that can be administered in a one-hour infusion, twice a year, following the starting dose.2,5,6
Results of clinical studies show that ublituximab significantly suppressed relapses and sub-clinical disease activity measured by MRI compared with oral teriflunomide 14 mg.2 The most important and frequently reported adverse reactions are infusion related reactions and infections.2 Ublituximab works by attaching to a target called CD20 on the surface of B cells. B cells are a type of white blood cell which are part of the immune system. In multiple sclerosis, the immune system attacks the protective layer around nerve cells. B cells are involved in this process. Ublituximab targets and removes the B cells and thereby reduces the chance of a relapse, relieves symptoms and slows down the progression of the disease.3
Dr. Jörg-Thomas Dierks, CEO of Neuraxpharm, commented: “NICE’s decision to recommend BRIUMVI® for RRMS endorses its therapeutic potential and highlights its ability to make a meaningful difference for people living with MS. Administered just twice a year, this treatment represents an effective solution for many patients and healthcare providers in the UK, alongside a cost saving for the UK’s National Health Service.”
Mark Slater, UK General Manager of Neuraxpharm, added: “Today’s milestone reflects our commitment to improving the lives of people living with MS in the UK”.
Neuraxpharm announced an agreement with TG Therapeutics in August 2023 to commercialise ublituximab outside the United States (US), Canada, Mexico, and excluding certain Asian countries that have been previously partnered.4
A comparison of ublituximab with ocrelizumab and ofatumumab using NICE’s cost comparison methods suggests ublituximab has similar benefits to and lower costs than ocrelizumab and ofatumumab, so ublituximab is recommended. NICE recommends the least expensive options of the available anti-CD20 treatments is used.1
https://www.nice.org.uk/guidance/gid-ta11268/documents/html-content-3
For further information please contact:
Optimum Strategic Communications
Nick Bastin / Charlotte Hepburne-Scott / Elena Bates
Tel: +44 (0)203 882 9621 Neuraxpharm@optimumcomms.com
About UBLITUXIMAB
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.2
Ublituximab is a chimeric monoclonal antibody that selectively targets CD20-expressing cells. CD20 is a cell surface antigen found on pre-B cells, mature and memory B cells but not expressed on lymphoid stem cells and plasma cells. The binding of Ublituximab to CD20 induces lysis of CD20+ B cells primarily through antibody-dependent cell-mediated cytotoxicity (ADCC) and, to a lesser extent through complement-dependent cytotoxicity (CDC). Due to a specific glycosylation pattern of its Fc region, Ublituximab displays an increased affinity for the FcγRIIIa (CD16) and antibody-dependent cellular cytolysis against B cells.2
The full SmPC can be consulted in: Briumvi 150 mg concentrate for solution for infusion | Electronic Medicines Compendium.
About Multiple Sclerosis
There are over 150,000 people living with MS in the UK, with nearly 7,100 new diagnoses each year.6 This means around 1 in every 400 people in the UK has MS.7 MS is more common in women than men, with approximately 97,730 women and 36,940 men affected.7 The prevalence is highest among those aged 50-59.7 Around 85% of people with multiple sclerosis are diagnosed with RRMS.8
About the Neuraxpharm Group
Neuraxpharm is a leading European specialty pharmaceutical company focused on the treatment of the central nervous system (CNS), including both psychiatric and neurological disorders. With more than 90% of its sales in CNS, it has a unique understanding and in-depth knowledge of this market built over 35 years. The company develops and commercialises a portfolio of more than 120 molecules through a direct presence in more than 20 countries in Europe, two in Latin America, the Middle East and globally via partners in more than 50 countries. Neuraxpharm is constantly innovating, with new products and solutions to address unmet patient needs and is expanding its portfolio through its pipeline, partnerships and acquisitions. For more information, please visit www.neuraxpharm.com.4
| This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Adverse events should be reported. Healthcare professionals are asked to report any suspected adverse reactions. UK reporting forms and information can be found via the Yellow Card Scheme www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in Google Play or the Apple App Store. Adverse events should also be reported to Neuraxpharm UK Ltd by emailing pv-uk@neuraxpharm.com. |
- National Institute for Health and Care Excellence (NICE) (2024) Ublituximab for treating relapsing multiple sclerosis. Available at: https://www.nice.org.uk/guidance/gid-ta11268/documents/html-content-3[Accessed 29/11/2024]
- Electronic Medicines Compendium (emc). (2024). BRIUMVI (Ublituximab) Summary of Product Characteristics: Product 100167. https://www.medicines.org.uk/emc/product/100167/smpc#gref [Accessed 29/11/2024]
- Briumvi Patient Information Leaflet https://www.medicines.org.uk/emc/files/pil.100167.pdf [Accessed 29/11/2024]
- TG Therapeutics, Inc., & Neuraxpharm Group. (2023). TG Therapeutics and Neuraxpharm Announce Ex-US Commercialization Agreement for BRIUMVI® (ublituximab-xiiy). https://www.neuraxpharm.com/news/tg-therapeutics-and-neuraxpharm-announce-ex-us-commercialization-agreement-for-briumvi-ublituximab-xiiy/ [Accessed 29/11/2024]
- Electronic Medicines Compendium (emc). (2024). OCREVUS (ocrelizumab) Summary of Product Characteristics: Product 8898. https://www.medicines.org.uk/emc/product/8898/smpc. [Accessed 29/11/2024]
- Electronic Medicines Compendium (emc). (2024). KESIMPTA (ofatumumab)Summary of Product Characteristics: Product 12433. https://www.medicines.org.uk/emc/product/12433/smpc#gref
- MS Society UK, https://www.mssociety.org.uk/what-we-do/our-work/our-evidence/ms-in-the-uk [Accessed 29/11/2024]
- MS Society UK, https://www.mssociety.org.uk/about-ms/types-of-ms/relapsing-remitting-ms [Accessed 29/11/2024]
NXUK/1124/56 date of preparation: November 2024