
CHMP adopts positive opinion for Riulvy (tegomil fumarate)- Neuraxpharm Pharmaceuticals
The Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Riulvy, intended for the treatment of adults and children from 13 years of age with relapsing remitting multiple sclerosis. The applicant is Neuraxpharm Pharmaceuticals S.L. Riulvy is a hybrid medicine of Tecfidera, which has been authorised in the EU since 30 January 2014. Riulvy contains a different active substance, but acts via the same active metabolite as Tecfidera, monomethyl fumarate. Studies have demonstrated the satisfactory quality of Riulvy and its bioequivalence to the reference product Tecfidera. Hybrid applications rely in part on the results of pre-clinical tests and clinical trials for a reference product and in part on new data.