Oct 22 A new hepatitis C drug made by Johnson &
Johnson showed an acceptable safety profile in clinical
trials, reviewers for the U.S. Food and Drug Administration said
The drug, simeprevir, was tested in combination with
standard hepatitis C drugs, peginterferon-alpha and ribavirin,
in adult patients who had failed previous interferon-based
therapy or had not received medication at all.
J&J shares were up nearly 1 percent to $92 in morning trade
on the New York Stock Exchange.
The major safety signal identified in the review of the drug
involved rash and/or photosensitivity and the FDA reviewers said
they plan to include a related warning in the drug's label. ()
The reviewers said that the drug would be categorized as a
"Pregnancy Category C" in labeling, which means that the
potential benefits of the drug may warrant its use in pregnant
women, even though animal trials showed the drug had some
adverse effects on a fetus.
The briefing documents were released prior to Thursday's
meeting of an advisory panel of independent experts to discuss
the drug's safety and efficacy, vote on an approval
recommendation, and the need for warnings or further trials.
Hepatitis C, an infection of the liver transmitted through
the blood, kills more than 15,000 Americans each year, mostly
from hepatitis C-related illnesses, such as cirrhosis and liver
Investors are currently focused on new hepatitis C
treatments that can exclude the use of the difficult-to-tolerate
injected drug interferon.
Sales of hepatitis C drugs that are needed to be taken with
interferon, like simeprevir, have been declining as patients
wait for the all oral treatment regimens that promise high
efficacy without the side effects of interferon.
Gilead Sciences Inc, Vertex Pharmaceuticals Inc
, AbbVie and Bristol-Myers Squibb are
all trying to come up with the first all-oral hepatitis C