The prescribing label for Biogen Inc’s big-selling oral multiple sclerosis drug Tecfidera has been updated to include a warning of potential liver injury that could require hospitalization, the company said on Wednesday.
However, the updated label says signs of liver injury resolved when those patients stopped taking the medicine.
Tecfidera, the world’s top-selling oral MS treatment, accounts for about a third of Biogen revenue. It had sales of $1.03 billion in the third quarter.