Biogen Idec’s MS drug gets European approval

pharmafile | February 4, 2014 | News story | Manufacturing and Production, Sales and Marketing |  Aubagio, Biogen IDEC, EU, MS, gilenya, tecdifera 

Biogen Idec’s oral multiple sclerosis drug Tecfidera has won approval in Europe as a first-line treatment for people with relapsing-remitting multiple sclerosis (RRMS).

Tipped as a blockbuster in waiting, the European Commission’s expected green light for Tecfidera (dimethyl fumarate) means it will be introduced into selected countries within weeks. 

“Tecfidera exemplifies our commitment to deliver innovative therapies that help people living with serious diseases,” said George Scangos, chief executive of Biogen Idec. 

First approved in the US in March last year it quickly became the country’s number one prescribed oral therapy for relapsing forms of multiple sclerosis (MS), despite being the third oral MS drug to reach the market behind Novartis’ Gilenya (fingolimod) and Sanofi’s Aubagio (teriflunomide). 

The EC approval was based on two global Phase III clinical trials, DEFINE and CONFIRM, as well as an ongoing extension study, ENDORSE, in which some patients had been followed for up to six and a half years. 

Tecfidera was shown to significantly reduce important measures of disease activity, including relapses and the development of brain lesions, as well as to slow disability progression, while demonstrating a favourable safety and tolerability profile. 

As of September last year approximately 35,000 patients were being treated with the drug according to Biogen Idec, which has seen strong sales produced for Tecfidera to date, something the EU approval can only contribute towards. 

Analysts on average forecast annual worldwide sales of the drug to reach $6 billion by 2019, with more than a third of that coming from Europe and other non-US markets according to data compiled by Reuters. 

Scangos said: “We already have seen Tecfidera’s significant impact on transforming the standard of care for MS where it is available and are excited to quickly bring its benefits to patients in the EU as well.”

Brett Wells