Neuraxpharm strengthens multiple sclerosis portfolio with the launch of Riulvy® (tegomil fumarate)

Germany is the first European country to launch the product, with further rollouts across Europe to follow

The next-generation oral fumarate therapy is designed to improve gastrointestinal tolerability and support long-term adherence

Barcelona, Spain and Düsseldorf, Germany – 2 October, 2025 – Neuraxpharm Group (Neuraxpharm), a leading European specialty pharmaceutical company focused on the treatment of central nervous system (CNS) disorders, today announces the launch of Riulvy^® (tegomil fumarate) in Germany, the product’s first introduction into the European market.

Tegomil fumarate is a next-generation oral fumarate therapy developed for the treatment of relapsing-remitting multiple sclerosis (RRMS) in adults and adolescents from 13 years of age¹. Designed as a ‘next-generation oral fumarate’, Riulvy^® provides equivalent efficacy to existing fumarate therapies while offering a favorable gastrointestinal tolerability profile. ^2,3

Around 2.8 million people live with MS worldwide with an average prevalence of 36 per 100,000 people. In Europe the average prevalence is even higher (133 per 100,000), with 300 per 100,000 in Germany.⁴

The launch marks another important milestone in Neuraxpharm’s ongoing commitment to enhancing treatment options in multiple sclerosis (MS), ensuring patients and physicians have new solutions to support long-term management of the disease.

Dr. Jörg-Thomas Dierks, Chief Executive Officer of Neuraxpharm, said: “This launch in Germany represents another significant achievement in our mission to bring innovative therapies to people living with CNS disorders. We now add a new oral fumarate therapy to our expanding multiple sclerosis portfolio which offers patients and neurologists more flexible, differentiated options in MS management.”

Tegomil fumarate, a co-development in collaboration with Tiefenbacher Group, received European Commission marketing authorisation in July 2025, with Germany as the first country to launch in October 2025. Additional launches across Europe are planned.

For further information please contact:

Optimum Strategic Communications
Nick Bastin / Charlotte Hepburne-Scott / Elena Bates / Nellie Stephens
Tel: +44 (0)203 882 9621
Neuraxpharm@optimumcomms.com

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. It has a unique understanding of the CNS market built over 40 years.

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.

The company has c.1,000 employees and develops and commercializes CNS products through a direct presence in more than 20 countries in Europe, two in Latin America, one in the Middle East, in Australia and globally via partners in more than 50 countries. Neuraxpharm is backed by funds advised by Permira.

Neuraxpharm manufactures many of its pharmaceutical products at Neuraxpharm Pharmaceuticals (formerly Laboratorios Lesvi) in Spain.

For more information, please visit https://www.neuraxpharm.com/

References

1. Riulvy 174 mg and 348 mg gastro-resistant hard capsules. Summary of Product Characteristics. European Medicines Agency (EMA). Available at: Riulvy, INN-tegomil fumarate.
2. Data on file, Neuraxpharm. Bioavailability study. (Comparable efficacy based on bioequivalent availability of the active metabolite inferred)
3. Fonseca M, et al. (2025). A randomized, double-blind study to compare the gastrointestinal tolerability and safety following oral administration of tegomil fumarate versus an equimolar dose of dimethyl fumarate to healthy participants. Poster presented at the 40th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS), 24–28 September 2025, Barcelona, Spain.
4. Multiple Sclerosis International Federation - MS Atlas - 3rd edition (September 2020) and European MS Platform. 2020 MS Barometer. Brussels: EMSP