Committee Recommends Boceprevir (Victrelis)
The European Medicines Agency's Committee for Medicinal Products
for Human Use has recommended approval of the HCV protease
inhibitor boceprevir (brand name Victrelis) for treatment
of chronic hepatitis C.
reported, the U.S. Food and Drug Administration last week
approved boceprevir for treatment of treatment-naive or prior
non-responder patients with genotype 1 hepatitis C virus (HCV)
infection, in combination with pegylated interferon plus ribavirin.
is an edited excerpt from a press release issued by boceprevir
developer Merck announcing the European recommendation.
Issues Positive Opinion for Merck's Victrelis (Boceprevir),
Oral Hepatitis C Virus (HCV) Protease Inhibitor
Station, NJ -- May 20, 2011 -- Merck (NYSE: MRK), known as MSD
outside the United States and Canada, today announced that the
Committee for Medicinal Products for Human Use (CHMP) of the
European Medicines Agency (EMA) has adopted a positive opinion
under accelerated assessment recommending approval of the investigational
medicine Victrelis (boceprevir) for the treatment of chronic
hepatitis C virus (HCV) genotype 1 infection, in combination
with peginterferon alfa and ribavirin, in adult patients with
compensated liver disease who are previously untreated or who
have failed previous therapy.
positive opinion will be reviewed by the European Commission,
which grants marketing authorization with unified labeling that
is valid in the 27 countries that are members of the European
Union (EU), as well as European Economic Area members, Iceland,
Liechtenstein and Norway.
are pleased with CHMP's recommendation to approve Victrelis in
combination with current standard therapy," said Peter S.
Kim, PhD, president, Merck Research Laboratories. "If approved,
Victrelis would represent the first in a new class of medicines
known as HCV protease inhibitors granted marketing authorization
in the European Union, and would offer an important new treatment
option for patients with chronic hepatitis C genotype 1."
CHMP positive opinion for Victrelis in combination with current
standard therapy is based on the efficacy and safety results from
two large Phase III clinical studies conducted at EU and U.S.
sites that evaluated approximately 1,500 adult patients with chronic
HCV genotype 1 infection. The HCV SPRINT-2 study involved 1,097
patients who were new to treatment (treatment naïve) and
the HCV RESPOND-2 study involved 403 patients who had failed previous
therapy. Final results of the studies were published in the New
England Journal of Medicine on March 31, 2011.
Victrelis is a Direct Acting Antiviral (DAA) agent designed to
interfere with the ability of the hepatitis C virus to replicate
by inhibiting a key viral enzyme (NS3/4A serine protease).
Victrelis in the U.S.: First-in-class oral HCV protease inhibitor
now available nationwide Victrelis was approved by the U.S. Food
and Drug Administration on May 13 and is now available to all
U.S. pharmacies nationwide, including specialty pharmacies. Any
U.S. pharmacy can order VICTRELIS through its wholesaler and have
it delivered within 24 hours.
To support the availability of Victrelis in the U.S., the company
has launched the Merck CARES (Commitment to Access, Resources,
Education & Support) program, which offers U.S. patients and
providers a single point of access for resources and support needed
to help patients as they initiate HCV treatment. Resources include
reimbursement support to help patients understand their insurance
coverage for Victrelis and 24/7 nurse phone support. Eligible
patients can also be referred to Merck's patient assistance program,
which can determine if the patient qualifies for free product.
Patients and providers can access the Merck CARES resources at
Victrelis is indicated in the U.S. for the treatment of chronic
hepatitis C genotype 1 infection, in combination with peginterferon
alfa and ribavirin, in adult patients (18 years of age and older)
with compensated liver disease, including cirrhosis, who are previously
untreated or who have failed previous interferon and ribavirin
The following points should be considered when initiating Victrelis
for treatment of chronic hepatitis C infection:
must not be used as monotherapy and should only be used
in combination with peginterferon alfa and ribavirin.
efficacy has not been studied in patients who have previously
failed therapy with a treatment regimen that includes Victrelis
or other HCV NS3/4A protease inhibitors.
in combination with peginterferon alfa and ribavirin has
not been studied in patients documented to be historical
null responders (less than a 2 log HCV-RNA decline by treatment
week 12) during prior therapy with peginterferon alfa and
ribavirin. The clinical studies included patients who were
poorly interferon responsive. Patients with less than 0.5
log HCV-RNA decline in viral load at treatment week 4 with
peginterferon alfa plus ribavirin alone are predicted to
have a null response (less than a 2 log HCV-RNA decline
by treatment week 12) to peginterferon alfa and ribavirin
interferon responsive patients who were treated with Victrelis
in combination with peginterferon alfa and ribavirin have
a lower likelihood of achieving a sustained virologic response
(SVR), and a higher rate of detection of resistance-associated
substitutions upon treatment failure, compared to patients
with a greater response to peginterferon alfa and ribavirin.
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For more information, visit www.merck.com.