New Treatment Option Approved for Relapsing-Remitting Multiple Sclerosis
On July 28, 2025, the European Commission (EC) approved tegomilfumarate for the treatment of relapsing-remitting multiple sclerosis (RRMS) in adults and adolescents aged 13 and older, following a recommendation from the European Medicines Agency (EMA). This adds a third fumarate-containing medication – alongside dimethyl fumarate and diroximelfumarate - to the treatment options available in Germany for RRMS.
These three medications share a common mechanism,ultimately acting through the metabolite monomethyl fumarate,leading to a classification of bioequivalence. The EMA assessed tegomilfumarate’s similarity to dimethyl fumarate and granted approval via a “hybrid” pathway, referencing the established efficacy and safety data of dimethyl fumarate (Tecfidera®, approved in the EU since 2014). The EMA documentation indicates a dosage correlation: 174mg of tegomilfumarate is considered equivalent to 120mg of dimethyl fumarate, and 348mg of tegomilfumarate corresponds to 240mg of dimethyl fumarate.
While the precise way these fumarates work in MS remains under investigation, they are known to have immunomodulatory effects, increasing regulatory cells and decreasing pro-inflammatory and cytotoxic T cells.Research also suggests a non-immunological effect within the central nervous system, possibly through activation of the NRF2 pathway – a key regulator of antioxidant genes.
Tegomilfumarate (marketed as Riulvy®) is administered orally as a hard capsule twice daily,with a specific dosing schedule. Patients begin with a “start dose” of 2 x 174mg for the first 7 days, followed by a “conservation dose” of 2 x 348mg from day 7 onwards. It is indeed possible that, similar to experiences with dimethyl fumarate, clinicians may adopt a more gradual dose escalation in practice.
Due to the potential for side effects and the complexity of MS treatment, initiation of tegomilfumarate therapy should be overseen by a physician experienced in managing multiple sclerosis.
The side effect profile of tegomilfumarate is expected to be similar to that of dimethyl fumarate, given their shared metabolic pathway. Common initial side effects include gastrointestinal issues like nausea, heartburn, abdominal pain, and diarrhea, as well as skin flushing. Existing warnings regarding leukopenia,progressive multifocal leukoencephalopathy (PML) risk,and pregnancy considerations,wich apply to dimethyl fumarate,also apply to tegomilfumarate.
Individuals seeking further information on dimethyl fumarate and diroximelfumarate can consult the current patient guides provided by the DMSG federal association and the disease-related competence-related multiple sclerosis (KKNMS).
