On 21 March 2013, the Committee for Medicinal Products for Human Use (CHMP) 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 applicant for this medicinal product is Biogen Idec Ltd. They may request a re-examination of any CHMP opinion, provided they notify the European Medicines Agency in writing of their intention within 15 days of receipt of the opinion.
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 (N07XX09), 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 relapsingremitting multiple sclerosis. The most common side effects are flushing and gastrointestinal events (e.g. diarrhoea, nausea and abdominal pain).
A pharmacovigilance plan for Tecfidera will be implemented as part of the marketing authorisation. Treatment with Tecfidera should be initiated under the supervision of a physician experienced in the treatment of the disease.
Detailed recommendations for the use of this product will be described in the summary of product characteristics (SmPC), which will be published in the European public assessment report (EPAR) and made available in all official European Union languages after the marketing authorisation has been granted by the European Commission.
The CHMP, on the basis of quality, safety and efficacy data submitted, considers there to be a favourable benefit-risk balance for Tecfidera and therefore recommends the granting of the marketing authorisation.
21 March 2013
Committee for Medicinal Products for Human Use (CHMP)
“A first-line license puts BG12 in pole position. I wonder if there will be any surprises around the corner; like a rare, but serious, adverse event? We now have to wait for NICE to deliberate.”