The FDA on Wednesday approved Biogen Idec's oral drug Tecfidera (dimethyl fumarate), formerly known as BG-12, for the treatment of adults with relapsing forms of multiple sclerosis, the company announced. The approval was supported by two Phase III trials including more than 2600 patients. In the studies, twice-daily Tecfidera lowered the proportion of patients who relapsed by 49 percent and reduced the annualised relapse rate by 53 percent.
Jefferies & Co. analyst Thomas Wei forecasts that Tecfidera will have sales of $2 billion in 2015 while analyst estimates project sales of $3.3 billion in 2017. Cowen & Co. analyst Eric Schmidt suggests that the therapy could capture as much as 20 percent of the market in its first year. Biogen Idec said it will launch the drug in the US within the coming days.
The European Medicines Agency's Committee for Medicinal Products for Human Use recommended approval of the drug in the EU earlier this month. Additionally, the drug was granted eight additional years of patent protection by the US Patent and Trademark office, extending protection until 2028.
For further analysis, read Spotlight On: Five key facts about Biogen Idec's Tecfidera.
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