Reuters Health Information: Possible liver injury added to label of Biogen MS drug Tecfidera
Possible liver injury added to label of Biogen MS drug Tecfidera
Last Updated: 2017-01-25
By Bill Berkrot
(Reuters) - The prescribing label for Biogen Inc's
big-selling oral multiple sclerosis drug Tecfidera (dimethyl
fumarate) 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.
The new liver injury information can be found in a warning
section under prescribing information on the drug's website
tecfidera.com. Biogen said the label changes were finalized with
the U.S. Food and Drug Administration on Jan. 19.
"Clinically significant cases of liver injury have been
reported in patients treated with Tecfidera in the postmarketing
setting. The onset has ranged from a few days to several months
after initiation of treatment with Tecfidera," the warning
A Biogen spokeswoman said there have been 14 cases of liver
injury reported out of some 230,000 patients treated with
Symptoms of liver injury include significant elevations
above normal of serum aminotransferases and bilirubin, the
While the abnormalities resolved when patients stopped
taking the medicine, some cases required hospitalization. None
of the reported cases resulted in liver failure, liver
transplant, or death, the warning says.
Liver enzyme monitoring is standard practice for many
multiple sclerosis drugs, so the warning does not represent an
added burden for prescribing physicians. It remains to be seen
if this tempers enthusiasm for the widely-used medicine or if it
will hurt sales.
"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," said RBC Capital Markets analyst
Michael Yee, who forecast 2017 Tecfidera sales exceeding $4
"There was already mention of some rare cases of elevated
liver enzymes in the initial label," Yee noted.
Biogen is scheduled to report fourth-quarter results on
Thursday and likely will be asked to discuss the implications of
the updated Tecfidera warning.