NICE Recommends ublituximab (BRIUMVI®▼) as an Option for Treating Relapsing-Remitting Multiple Sclerosis (RRMS)1

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  

1. 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]
2. 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]
3. Briumvi Patient Information Leaflet https://www.medicines.org.uk/emc/files/pil.100167.pdf [Accessed 29/11/2024]
4. 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]
5. 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]
6. Electronic Medicines Compendium (emc). (2024). KESIMPTA (ofatumumab) Summary of Product Characteristics: Product 12433. https://www.medicines.org.uk/emc/product/12433/smpc#gref
7. MS Society UK, https://www.mssociety.org.uk/what-we-do/our-work/our-evidence/ms-in-the-uk [Accessed 29/11/2024]
8. MS Society UK, https://www.mssociety.org.uk/about-ms/types-of-ms/relapsing-remitting-ms [Accessed 29/11/2024]