BRUSSELS – 2025/09/22 12:14:17 – The European Union has expanded its arsenal against multiple sclerosis. On July 28,2025,the European Commission (EC) granted approval for tegomilfumarate,a new treatment for adult patients,children,and adolescents aged 13 and older,who are diagnosed with relapsing-remitting multiple sclerosis (RRMS). The decision followed a proposal from the European drug agency (EMA).

Tegomilfumarate, marketed as Riulvy®, joins dimethyfumarate and diroximelfumarate as fumerate-based options available in Germany for RRMS therapy. These medications share a common mechanism,influencing the main metabolite monomethyl fumarate,leading to discussions of bioequivalence. The EMA’s assessment of tegomilfumarate, in comparison to dimethylfumarate (Tecfidera®, EU-approved as 2014), supported its approval as a hybrid medicine.EMA documents indicate the relative effectiveness, noting that 174 mg of tegomilfumarate corresponds to 120 mg of dimethylfumarate, and 348 mg of tegomilfumarate corresponds to 240 mg of dimethylfumarate.

While the precise action of fumarate-containing drugs in treating MS remains under investigation, thay are known to possess immunomodulatory properties. These drugs increase regulatory cells while decreasing pro-inflammatory and cytotoxic T cells. Furthermore,they are believed to exert a non-immunological effect within the central nervous system by activating anti-oxidative genes (NRF2).

Riulvy® is administered orally as a hard capsule twice daily, once in the morning and once in the evening. The approved initial dosage is 2 x 174 mg (“start dose”) for the first week, followed by a maintenance dosage of 2 x 348 mg (“conservation dose”) from day seven onward. Whether a slower dose escalation will be adopted in clinical practice, as seen with dimethyl fumarate, remains to be determined.

Initiation of tegomilfumarate therapy should occur under the guidance of a physician experienced in treating multiple sclerosis.

The side effect profile mirrors that of monomethyl fumarate, stemming from the metabolism of fumarate-containing active ingredients. Common side effects at the beginning of treatment include gastrointestinal issues (nausea, heartburn, abdominal pain, and diarrhea) and skin flushing. Standard warnings related to leukopenia, PML risk, and pregnancy, also apply, similar to dimethylfumarate.

Additional information on dimethyl fumarate and diroximelfumarate can be found in resources from the DMSG federal association and the disease-related competence-related multiple sclerosis (KKNMS).