The US Food and Drug Administration (FDA) has approved dimethyl fumarate (Tecfidera, Biogen Idec) for the treatment of relapsing-remitting multiple sclerosis (MS).
The approval brings to 3 the number of oral agents now approved for this indication. Fingolimod (Gilenya, Novartis) was the first, in September 2010, followed by teriflunomide(Aubagio, Genzyme/Sanofi) earlier this year.
In October 2012, the company announced that the FDA had extended review of dimethyl fumarate for an additional 3 months to allow more time to review the application, although without asking for additional studies.
The application is based on findings from the Determination of the Efficacy and safety of oral Fumarate IN rElapsing-remitting MS (DEFINE) trial and the Comparator and an Oral Fumarate in RRMS (CONFIRM) trial, both published in the September 20 issue of the New England Journal of Medicine. The trials were funded by Biogen Idec.
Full results of the 2 phase 3 trials evaluating the effect of oral dimethyl fumarate in patients with MS showed that the investigational agent reduced relapse rates, disease activity on imaging, and, in 1 trial, progression of disability.
Biogen Idec received a new patent for the 480-mg dosing regimen of dimethyl fumarate earlier this month that will protect their exclusivity with the drug until 2028.
On March 22, the European Medicines Agency's Committee for Medicinal Products for Human Userecommended marketing authorization for both dimethyl fumarate and teriflunomide in the European Union as first-line oral agents in the treatment of relapsing-remitting MS.
Additional TECFIDERA Updates
- On March 22, 2013 the Committee for Medicinal Products for Human Use (CHMP) in the European Union (EU) issued a positive opinion recommending a marketing authorization be granted for TECFIDERA as a first-line oral treatment for adults with relapsing-remitting multiple sclerosis (RRMS). The CHMP's recommendation has now been referred to the European Commission (EC), which grants marketing authorization for medicines in the European Union.
- On March 19, 2013, the United States Patent and Trademark Office issued a patent covering the dosing regimen of daily administration of 480 mg of TECFIDERA. This patent will expire in 2028.
- The European Patent Office recently determined that Biogen Idec’s application for a patent covering the dosing regimen of daily administration of 480 mg of TECFIDERA is allowable. Once granted, the EU patent would also expire in 2028.