Dimethylfumarat (2) – Tecfidera®

• Clinical trials
  • The pharmaceutical manufacturer has submitted data from the randomised, open-label CONNECT Part 1 trial for the benefit assessment, in which dimethyl fumarate was compared with the active ingredient interferon-beta 1a (medicinal product: Avonex™) over a period of 96 weeks.

Children and adolescents aged ≥ 13 to < 18 years with relapsing-remitting multiple sclerosis (RRMS) who have not yet received disease-modifying therapy, or children and adolescents previously treated with disease-modifying therapy whose disease is not highly active

• For children and adolescents aged ≥ 13 to < 18 years with relapsing-remitting multiple sclerosis (RRMS) who have not yet received disease-modifying therapy, or children and adolescents who have previously been treated with disease-modifying therapy and whose disease is not highly active, the additional benefit is not proven.
• The additional benefit of dimethyl fumarate compared with the appropriate comparator therapy is therefore not proven.
• For children and adolescents aged ≥ 13 to < 18 years with relapsing-remitting multiple sclerosis (RRMS) who have not yet received disease-modifying therapy, or children and adolescents who have previously received disease-modifying therapy and whose disease is not highly active, no data are available comparing dimethyl fumarate with the appropriate comparator therapy.
• Overall review
  • In summary, there are therefore no suitable data available for comparing dimethyl fumarate with the appropriate comparator therapy.

Courtesy translation only, please refer to the German original.