The label change, finalized with the Food and Drug Administration Jan. 19, was made after 14 cases of liver injury were reported out of 230,000 patients taking the drug, a Biogen spokeswoman told Reuters.
“Clinically significant cases of liver injury have been reported in patients treated with Tecfidera in the postmarketing setting,” the warning label reads. “The onset has ranged from a few days to several months after initiation of treatment with Tecfidera.”
Liver abnormalities resolved when patients stopped taking Tecfidera, although some cases required hospitalization, according to the report. None of the reported cases caused liver failure, liver transplant or death.
“While this is something to be highlighted to physicians, in my opinion this is not going to materially change market share or future [sales] projections,” RBC Capital Markets analyst Michael Yee told Reuters.
Tecfidera is the world’s top selling MS drug. The medication, which accounts for about a third of Biogen’s revenue, had sales of $1.03 billion in the third quarter of 2016, according to the report.
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