FDA NEWS RELEASE
For Immediate Release: Nov. 22, 2013
FDA approves new treatment for hepatitis C virus
U.S. Food and Drug Administration today approved Olysio (simeprevir), a
new therapy to treat chronic hepatitis C virus infection.
C is a viral disease that causes inflammation of the liver that can
lead to diminished liver function or liver failure. Most people infected
with the hepatitis C virus have no symptoms of the disease until liver
damage becomes apparent, which may take several years. Most of these
people then go on to develop chronic hepatitis C. Some will also develop
scarring and poor liver function (cirrhosis) over many years, which can
lead to complications such as bleeding, jaundice (yellowish eyes or
skin), fluid accumulation in the abdomen, infections or liver cancer.
According to the Centers for Disease Control and Prevention, about 3.2
million Americans are infected with the hepatitis C virus.
is a protease inhibitor that blocks a specific protein needed by the
hepatitis C virus to replicate. It is to be used as a component of a
combination antiviral treatment regimen. In clinical studies, Olysio was
evaluated in combination with peginterferon-alfa and ribavirin, two
drugs also used to treat hepatitis C virus infection. Olysio is intended
for adults with compensated liver disease (a diseased liver that is
still functioning), including cirrhosis, who have not received treatment
for their infection (treatment naïve) or for whom previous treatment
has not been effective (treatment experienced).
“Olysio is the
third FDA-approved protease inhibitor to treat chronic hepatitis C virus
infection, and provides health professionals and patients with a new,
effective treatment for this serious disease,” said Edward Cox, M.D.,
director of the Office of Antimicrobial Products in the FDA’s Center for
Drug Evaluation and Research.
In 2011, the FDA approved Victrelis
(boceprevir) and Incivek (telaprevir) for the treatment of hepatitis C.
Olysio was reviewed under the FDA’s priority review program, which
provides for an expedited review of drugs that, if approved, would
provide safe and effective therapy when no satisfactory alternative
therapy exists, or offer significant improvement compared to available
The safety and effectiveness of Olysio were evaluated
in five clinical studies of 2,026 treatment-naive and
treatment-experienced participants randomly assigned to receive Olysio
plus peginterferon-alfa and ribavirin or placebo plus peginterferon-alfa
and ribavirin. The studies were designed to measure whether a
participant’s hepatitis C virus was no longer detected in the blood at
least 12 weeks after finishing treatment (sustained virologic response),
suggesting a participant’s infection had been cured.
showed 80 percent of treatment-naive participants given Olysio plus
peginterferon-alfa and ribavirin achieved sustained virologic response,
compared to 50 percent of participants receiving peginterferon-alfa and
ribavirin alone. In one of the studies with treatment-experienced
participants whose infection returned (prior relapsers), 79 percent
receiving Olysio plus peginterferon-alfa and ribavirin achieved
sustained virologic response compared to 37 percent of participants
receiving peginterferon-alfa and ribavirin alone.
examined Olysio’s safety and effectiveness in treatment-experienced
participants, including prior relapsers, those who partially responded
to prior therapy (partial responders) and those who did not respond to
prior therapy (null responders). Adding Olysio improved response rates
in each of these subgroups compared to peginterferon-alfa and ribavirin
A reduction in Olysio’s effectiveness was observed in
participants infected with the genotype 1a hepatitis C virus with an NS3
Q80K polymorphism, a strain of the hepatitis C virus commonly found in
the United States. Olysio’s drug label includes a recommendation to
screen for the presence of the strain prior to beginning therapy and to
consider alternative therapy if the strain is detected.
common side effects reported in clinical study participants treated with
Olysio in combination with peginterferon-alfa and ribavirin were rash
(including photosensitivity), itching (pruritis) and nausea. Serious
photosensitivity reactions resulting in hospitalization were reported.
Patients will be advised to limit sun exposure and to use sun protective
measures during treatment with Olysio in combination with peginterferon
alfa and ribavirin. Olysio should not be used alone to treat chronic
hepatitis C infection.
Olysio is marketed by Janssen
Pharmaceuticals, based in Raritan, N.J. Victrelis is marketed by
Whitehouse Station, N.J.-based Merck, and Incivek is marketed by
Cambridge, Mass.-based Vertex Pharmaceuticals.
FDA, an agency within the U.S. Department of Health and Human Services,
protects the public health by assuring the safety, effectiveness, and
security of human and veterinary drugs, vaccines and other biological
products for human use, and medical devices. The agency also is
responsible for the safety and security of our nation’s food supply,
cosmetics, dietary supplements, products that give off electronic
radiation, and for regulating tobacco products.