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 Aubagio 14 mg film-coated tablet intended for the treatment of multiple sclerosis. The Committee also concluded that the active substance contained in Aubagio, teriflunomide, could not be considered to be a new active substance.
The applicant for this medicinal product is Sanofi-aventis groupe. 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 (MS)”.
Teriflunomide is a selective immunosuppressant (L04AA31) with anti-inflammatory properties. The exact mechanism by which teriflunomide exerts its therapeutic effect in MS is not fully understood, but it is known to reduce the proliferation of lymphocytes by blocking the mitochondrial enzyme dihydroorotate dehydrogenase (DHO-DH).
The benefit with Aubagio is its ability to reduce the relapse rate in patients with relapsing remitting MS. The most common side effects are upper respiratory tract infections, urinary tract infections, diarrhoea, nausea, paraesthesia (pins and needles), alopecia (loss of hair) and increase in the liver enzyme alanine aminotransferase.
A pharmacovigilance plan for Aubagio will be implemented as part of the marketing authorisation. Treatment with Aubagio should be initiated and supervised by a physician experienced in the management of multiple sclerosis.
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 Aubagio and therefore recommends the granting of the marketing authorisation.
21 March 2013
Committee for Medicinal Products for Human Use (CHMP)
“It doesn’t just rain, it pours. MSers have been waiting decades for a first-line oral and they get two approvals on the same day. Teriflunomide provides is an alternative to the injectable 1st-line therapies. Pity it took so long for it to get through the pipeline. Let’s hope NICE doesn’t spoil the party.”