An important new multiple sclerosis drug from Biogen Idec Inc. moved a step closer to getting regulatory approval in Europe after an advisory panel issued a positive opinion on the drug called Tecfidera, the biotechnology company said Friday.
Tecfidera, an oral treatment for relapsing multiple sclerosis, was approved by the US Food and Drug Administration in March. Early sales were so strong that in late October, Biogen Idec boosted its 2013 forecast. At the time, ISI Group analyst Mark Schoenebaum wrote: ‘‘Tecfidera crushed it. This is really, truly, incredible.’’
In a Friday press release about the regulatory process in Europe, Biogen Idec said that the “Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has determined that dimethyl fumarate in Tecfidera qualifies as a new active substance (NAS). This designation will provide 10 years of regulatory exclusivity for Tecfidera in the European Union (EU).”
In a statement, Biogen Idec executive vice president of research and development Douglas Williams said: “We are heartened by the CHMP’s NAS determination, which brings us closer to our goal of providing this important new treatment to multiple sclerosis (MS) patients in Europe. We are ready to introduce Tecfidera in EU countries shortly after anticipated approval. This designation validates the tremendous investment we have made in Tecfidera and enables us to invest in future research focused on reversing the course of MS and hopefully one day finding a cure for patients.”
One of Biogen Idec’s specialties is MS drugs. Its other MS drugs include Avonex and Tysabri.
Biogen Idec is just about to complete the relocation of its headquarters from Weston to Cambridge.