|[December 19, 2012]
Vertex Announces Update to U.S. Prescribing Information for INCIVEK® (telaprevir)
CAMBRIDGE, Mass. --(Business Wire)--
Vertex (News - Alert) Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced that
the INCIVEK® (telaprevir) label in the United States has been
updated to include a Boxed Warning stating that fatal and non-fatal
serious skin reactions have been reported in patients taking INCIVEK
combination treatment. Fatal cases of serious skin reactions have been
reported in patients with progressive rash and systemic symptoms who
continued to receive INCIVEK combination treatment after a serious skin
reaction was identified.
Rash and serious skin reactions are known adverse events associated with
INCIVEK combination treatment and were previously included in the
warnings and precautions section of the label. Given the severity of the
events reported in the post-marketing setting, and the importance of
discontinuing INCIVEK combination treatment in the event of one of these
reactions, the information has been given greater prominence through a
"The safety of people taking our medicines is our first priority, and we
are committed to ensuring that patients and physicians are aware of the
label update to help them use INCIVEK properly," said Robert Kauffman,
M.D., Ph.D., Senior Vice President and Chief Medical Officer at Vertex.
"We will continue to educate physicians to follow the rash management
plan developed while INCIVEK was in clinical trials and the information
contained in the updated label."
In Phase 3 clinical trials, less than 1 percent of people who received
INCIVEK combination treatment experienced a serious skin reaction. These
serious skin reactions required hospitalization and all patients
recovered. For serious skin reactions, INCIVEK combination treatment
must be discontinued immediately, and patients should be promptly
referred for urgent medical care.
The INCIVEK label was also updated to include additional information on
the time to onset and management of anemia.
INCIVEK® (telaprevir) tablets is an oral medicine that
acts directly on the hepatitis C virus protease, an enzyme essential for
viral replication. INCIVEK has been prescribed to more than 50,000
patients in the United States. Approximately three out of four U.S.
patients who are prescribed a direct-acting antiviral for the treatment
of genotype 1 chronic hepatitis C (HCV) receive INCIVEK combination
In Phase 3 clinical studies, 79 percent of people who had not previously
been treated for HCV achieved a viral cure following treatment with
INCIVEK combination therapy, compared with 46 percent of those who
received pegylated-interferon and ribavirin (P/R) alone. Among people
who were treated previously but did not achieve a viral cure, in the
Phase 3 studies: 86 percent of relapsers achieved a viral cure with
INCIVEK combination therapy compared to 22 percent with P/R alone; 59
percent of partial responders achieved a viral cure compared with 15
percent with P/R alone; and 32 percent of null responders achieved a
viral cure compared with 5 percent with P/R alone. In addition, many
people are eligible to complete treatment with INCIVEK combination
therapy in 24 weeks - half the time required for treatment with P/R
INCIVEK was approved by the U.S. Food and Drug Administration (FDA) in
May 2011 and by Health Canada in August 2011 for use in combination with
pegylated-interferon and ribavirin for adults with genotype 1 chronic
hepatitis C with compensated liver disease (some level of damage to the
liver but the liver still functions), including cirrhosis (scarring of
the liver). INCIVEK is approved for people who are new to treatment, and
for people who were treated previously with interferon-based treatment
but who did not achieve a sustained viral response, or viral cure
(relapsers, partial responders and null responders).
Vertex developed telaprevir in collaboration with Janssen and Mitsubishi (News - Alert)
Tanabe Pharma. Vertex has rights to commercialize telaprevir in North
America where it is being marketed under the brand name INCIVEK
(in-SEE-veck). Janssen has rights to commercialize telaprevir in Europe,
South America, Australia, the Middle East and certain other countries.
In September 2011, telaprevir was approved in the European Union and
Switzerland. Telaprevir is known as INCIVO® in Europe.
Mitsubishi Tanabe Pharma has rights to commercialize telaprevir in Japan
and certain Far East countries. In September 2011, telaprevir was
approved in Japan and is known as Telavic®.
IMPORTANT SAFETY INFORMATION
INCIVEK® (telaprevir) is a prescription medicine used
with the medicines peginterferon alfa and ribavirin to treat chronic
(lasting a long time) hepatitis C genotype 1 infection in adults with
stable liver problems, who have not been treated before or who have
failed previous treatment. It is not known if INCIVEK is safe and
effective in children under 18 years of age.
Important Safety Information
INCIVEK® (telaprevir) should always be usedin
combination with peginterferon alfa and ribavirin. INCIVEK combination
treatment may cause serious side effects including skin rash and serious
skin reactions, anemia (low red blood cell count) that can be severe,
and birth defects or death of an unborn baby.
Skin rashes are common with INCIVEK combination treatment. Sometimes
these skin rashes and other skin reactions can become serious, require
treatment in a hospital, and may lead to death. Patients should
call their healthcare provider right away if they develop any skin
changes during treatment with INCIVEK. Their healthcare provider
will decide if they need treatment or if they need to stop INCIVEK or
any of their other medicines. Patients should not stop taking INCIVEK
combination treatment without talking with their healthcare provider
Patients' healthcare providers will do blood tests regularly to check
for anemia. If anemia is severe, the healthcare providers may tell them
to stop taking INCIVEK.
INCIVEK combined with peginterferon alfa and ribavirin may cause birth
defects or death of an unborn baby. Therefore, a patient should not take
INCIVEK combination treatment if she is pregnant or may become pregnant,
or if he is a man with a sexual partner who is pregnant. Females who can
become pregnant and females whose male partner takes these medicines
must have a negative pregnancy test before starting treatment, every
month during treatment, and for 6 months after treatment ends. Patients
must use two forms of effective birth control during treatment and for 6
months after all treatment has ended. These two forms of birth control
should not contain hormones, as these may not work during treatment with
INCIVEK and other medicines can affect each other and can also cause
side effects that can be serious or life-threatening. There are certain
medicines patients cannot take with INCIVEK combination treatment.
Patients should tell their healthcare providers about all the medicines
they take, including prescription and non-prescription medicines,
vitamins and herbal supplements.
The most common side effects of INCIVEK combination treatment include
itching, nausea, diarrhea, vomiting, anal or rectal problems (including
hemorrhoids, discomfort , burning or itching around or near the anus),
taste changes and tiredness. There are other possible side effects of
INCIVEK, and side effects associated with peginterferon alfa and
ribavirin also apply to INCIVEK combination treatment. Patients should
tell their healthcare provider about any side effect that bothers them
or doesn't go away.
Please see full Prescribing Information including Boxed Warning, and the
Medication Guide for INCIVEK available at www.INCIVEK.com.
About Hepatitis C
Hepatitis C is a serious liver disease caused by the hepatitis C virus,
which is spread through direct contact with the blood of infected people
and ultimately affects the liver.1 Chronic hepatitis C can
lead to serious and life-threatening liver problems, including liver
damage, cirrhosis, liver failure or liver cancer.1 Though
many people with hepatitis C may not experience symptoms, others may
have symptoms such as fatigue, fever, jaundice and abdominal pain.1 Unlike
HIV and hepatitis B virus, chronic hepatitis C can be cured.2
If treatment is not successful and a person does not achieve a viral
cure, they remain at an increased risk for progressive liver disease.3,4
More than 170 million people worldwide are chronically infected with
hepatitis C.5 In the United States, up to 5 million people
have chronic hepatitis C and 75 percent of them are unaware of their
infection.6,7 Hepatitis C is four times more prevalent in the
United States compared to HIV.7 The majority of people with
hepatitis C in the United States were born between 1945 and 1965,
accounting for 82 percent of people with the disease.8 Hepatitis
C is the leading cause of liver transplantations in the United States
and is reported to contribute to 15,000 deaths annually.9,10
By 2029, total annual medical costs in the United States for people with
hepatitis C are expected to more than double, from $30 billion in 2009
to approximately $85 billion.11
Vertex creates new possibilities in medicine. Our team discovers,
develops and commercializes innovative therapies so people with serious
diseases can lead better lives.
Vertex scientists and our collaborators are working on new medicines to
cure or significantly advance the treatment of hepatitis C, cystic
fibrosis, rheumatoid arthritis and other life-threatening diseases.
Founded more than 20 years ago in Cambridge, Mass., we now have ongoing
worldwide research programs and sites in the U.S., U.K. and Canada.
Today, Vertex has more than 2,000 employees around the world, and for
three years in a row, Science magazine has named Vertex one of
its Top Employers in the life sciences
Vertex's press releases are available at www.vrtx.com.
Special Note Regarding Forward-Looking Statements
This press release contains forward-looking statements as defined in the
Private Securities Litigation Reform Act of 1995, including, without
limitation, Dr. Kauffman's statements in the third paragraph of this
press release. While the company believes the forward-looking statements
contained in this press release are accurate, there are a number of
factors that could cause actual events or results to differ materially
from those indicated by such forward-looking statements. Those risks and
uncertainties include the risks listed under Risk Factors in Vertex's
annual report and quarterly reports filed with the Securities and
Exchange Commission and available through Vertex's website at www.vrtx.com.
Vertex disclaims any obligation to update the information contained in
this press release as new information becomes available.
1 Centers for Disease Control and Prevention. Hepatitis C
Fact Sheet: CDC Viral Hepatitis. Available at: http://www.cdc.gov/hepatitis/HCV/PDFs/HepCGeneralFactSheet.pdf
Updated June 2010. Accessed September 21, 2012.
2 Pearlman BL and Traub N. Sustained Virologic Response to
Antiviral Therapy for Chronic Hepatitis C Virus Infection: A Cure and So
Much More. Clin Infect Dis. 2011 Apr;52(7):889-900.
3 Morgan TR, Ghany MG, Kim HY, Snow KK, Lindsay K, Lok AS.
Outcome of sustained virological responders and non-responders in the
Hepatitis C Antiviral Long-Term Treatment Against Cirrhosis (HALT-C)
trial. Hepatology. 2008;50(Suppl 4):357A (Abstract 115).
4 Veldt BJ, Heathcote J, Wedmeyer H. Sustained virologic
response and clinical outcomes in patients with chronic hepatitis C and
advanced fibrosis. Annals of Internal Medicine. 2007; 147: 677-684.
5 Ghany MG, Strader DB, Thomas DL, Seeff, LB. Diagnosis,
management and treatment of hepatitis C; An update. Hepatology.
6 Chak, E, et. al. Hepatitis C Virus Infection In USA: An
Estimate of True Prevalence. Liver Intl. 2011;1096 -1098.
7 Institute of Medicine of the National Academies. Hepatitis
and liver cancer: a national strategy for prevention and control of
hepatitis B and C. Colvin HM and Mitchell AE, ed. Available at: http://www.iom.edu/Reports/2010/Hepatitis-and-Liver-Cancer-A-National-Strategy-for-Prevention-and-Control-of-Hepatitis-B-and-C.aspx
Updated January 11, 2010. Accessed September 21, 2012.
8 Smith, BD, et al. Hepatitis C Virus Antibody Prevalence,
Correlates and Predictors among Persons Born from 1945 through 1965,
United States, 1999-2008. AASLD 2011 Annual Meeting.
9 Volk MI, Tocco R, Saini S, Lok, ASF. Public health impact
of antiviral therapy for hepatitis C in the United States. Hepatology.
10 Ly KN, et al. The Increasing Burden of Mortality From
Viral Hepatitis in the United States Between 1999 and 2007. Ann
Intern Med. 2012;156:271-278.
11 Pyenson B, Fitch K, and Iwasaki K. Consequences of
Hepatitis C Virus (HCV): Costs of a Baby Boomer Epidemic of Liver
Disease. Milliman, Inc. May 2009. Available at: http://www.vrtx.com/assets/pdfs/MillimanReport.pdf
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