US-based Biogen Idec has received approval from the European Commission (EC) for its Tecfidera (dimethyl fumarate) as a first-line oral treatment for people with relapsing-remitting multiple sclerosis (RRMS), the most common form of multiple sclerosis (MS).
Approval is based on a clinical development programme that included two global Phase III clinical trials, DEFINE, CONFIRM and an ongoing extension study ENDORSE, where some patients have been followed for up to six and a half years.
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Tecfidera has been clinically shown to reduce important measures of disease activity, including relapses and the development of brain lesions, as well as to slow disability progression, while showing a favourable safety and tolerability profile.
Biogen Idec chief executive officer George 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."
In DEFINE, the drug administered twice-daily has reduced the proportion of patients who relapsed by 49%, the annualised relapse rate (ARR) by 53%, and the risk of 12-week confirmed disability progression, as measured by the expanded disability status scale (EDSS), by 38% compared with placebo at two years.
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While in CONFIRM, which also included an active reference comparator of glatiramer acetate (GA) compared with placebo, twice-daily Tecfidera reduced ARR by 44% and the proportion of patients who relapsed by 34% compared with placebo at two years.
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By GlobalDataIn both DEFINE and CONFIRM, the drug reduced lesions in the brain compared with placebo, as measured by magnetic resonance imaging (MRI).
The most common adverse events (AEs) related with Tecfidera were flushing and gastrointestinal (GI) events.
The company intends to launch Tecfidera in initial European Union (EU) countries in the coming weeks.
Tecfidera was approved in March 2013 by the US Food and Drug Administration (FDA) and it has also received approvals in Canada and Australia.
Image: Tecfidera is the fourth therapy Biogen Idec offers to people living with MS. Photo: courtesy of freedigitalphotos.net.
