The UK’s National Institute for Health and Care Excellence (NICE) is calling on US biotech firm Biogen Idec (Nasdaq: BIIB) to provide more information on its multiple sclerosis drug Tecfidera (dimethyl fumarate).
In draft guidance published for consultation, NICE has requested a series of clarifications on the evidence submitted by the manufacturer. NICE is appraising Tecfidera as a treatment for adults with relapsing-remitting multiple sclerosis. The independent Appraisal Committee, which develops the guidance on behalf of NICE, considered evidence from the manufacturer, clinical experts, patient representatives and an independent critique of the manufacturer's submission.
Tecfidera, which was approved in the USA in March 2013 and in Europe this month (The Pharma Letter February 3), is expected to become a dominant player in the MS market, with peak annual sales of $4.5 billion forecast by 2020.
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