Neurology Xagena
The Committee for Medicinal Products for Human Use ( CHMP ) has adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Tecfidera 120 mg and 240 mg, gastro-resistant hard capsules, intended for the treatment of adult patients with relapsing remitting multiple sclerosis.
The approved indication is: treatment of adult patients with relapsing remitting multiple sclerosis.
The active substance of Tecfidera is Dimethyl fumarate, a nervous system drug, that primarily acts by triggering the activation of the nuclear factor ( erythroid-derived 2 )-like 2 ( Nrf2 ) transcriptional pathway.
The benefits with Tecfidera are its ability to reduce the number of relapses in patients with relapsing-remitting multiple sclerosis.
The most common side effects are flushing and gastrointestinal events ( e.g. diarrhoea, nausea and abdominal pain ).
The CHMP considers that Dimethyl fumarate is different from Fumaderm. Therefore, the active substance of Tecfidera, Dimethyl fumarate, is a new active substance. This conclusion is based on the review of the scientific evidence, and in line with clarification provided by the European Commission that:
i) a new active substance is a chemical substance not previously authorised as a medicinal product in the European Union, and,
ii) Dimethyl fumarate is part of the medicinal product Fumaderm authorised in 1994 in Germany, but it has not been previously authorised as a medicinal product in the European Union. ( Xagena )
Source: European Medicines Agency, 2013
XagenaMedicine_2013
