News Release, Dec 3, 2002
FDA Approves Pegasys (peginterferon alfa-2a) in Combination
with CopegusT (ribavirin) for the Treatment of Hepatitis C
New treatment offers dosing regimen based on hepatitis C virus
strain
NUTLEY, N.J. (December 3, 2002) Roche announced today that the U.S.
Food and Drug Administration (FDA) has approved combination therapy
with Pegasys (peginterferon alfa-2a), a pegylated interferon, and
CopegusT (ribavirin) for the treatment of adults with chronic
hepatitis C who have compensated liver disease and have not
previously been treated with interferon alpha. Patients in whom
efficacy was demonstrated included patients with compensated liver
disease and histological evidence of cirrhosis (Child-Pugh class
A).
Pegasys and Copegus combination therapy was granted priority
review designation by the FDA. Pegasys was approved as monotherapy
for the treatment of adults with chronic hepatitis C on October 16,
2002. Currently, 2.7 million Americans are chronically infected
with hepatitis C. "Roche has taken a leadership role in advancing
hepatitis C therapy by researching approaches to reduce the
duration of treatment with Pegasys and Copegus and the dose of
Copegus therapy for certain patients," George B. Abercrombie,
President & Chief Executive Officer - Hoffmann-La Roche Inc.
"Today, Roche can proudly offer Americans with hepatitis C a new
treatment choice Pegasys and Copegus combination therapy."
"Different genotypes of the hepatitis C virus need to be
approached differently. Certain genotypes of the hepatitis C virus
are easier t treat while others are stubborn and more difficult to
treat," said Pegasys investigator, David Bernstein, MD, Director of
Hepatology at North Shore University Hospital, Manhasset, NY. "With
Pegasys combination therapy, we can now tailor the dose and
duration of a patient's therapy to the genotype of the virus."
Pivotal Studies
Pegasys and Copegus combination therapy was granted approval based
on the results of two pivotal Phase III clinical trials that
demonstrate it is an effective treatment for patients with chronic
hepatitis C. The pivotal study completed most recently evaluated
the effects of the duration (24 weeks compared to 48 weeks) of
Pegasys 180mcg as a subcutaneous injection once weekly and Copegus
treatment (24 weeks compared to 48 weeks) and the daily dose of
Copegus (800mg compared to 1000 for patients weighing less than 75
kg and 1200 for patients equal to or more than 75 kg) in patients
with chronic hepatitis C. The number of patients who received
medication in the study was 1284.
The study showed that patients with strains of the hepatitis C
virus known as genotype non-1 (predominantly 2 and 3) achieved
similar sustained virological response rates when treated with a 24
week regimen of Pegasys and 800mg Copegus compared to a 48 week
regimen of Pegasys and 1000-1200 Copegus. Genotype non-1
(predominantly 2 and 3) patients who were treated with the 24 week
lower Copegus dose regimen experienced fewer side effects.
Sustained virological response refers to a patient's continued
undetectable serum hepatitis C RNA levels 24 weeks after finishing
a course of treatment.
Genotype 1 patients who were treated with the a 48 week regimen
of Pegasys and 1000-1200 Copegus had higher sustained virological
response rate compared to those treated with the 24 week lower
Copegus dose regimen.
Sustained virological response rates for these groups treated
with Pegasys and Copegus therapy were:
- Genotype 1: 48 week duration with 1000 1200mg Copegus: 51
percent
- Genotype non-1: 24 week duration with 800mg Copegus: 82
percent
The other pivotal study was published in the September 26, 2002
New England Journal of Medicine and showed that Pegasys 180mcg and
Copegus 1000 1200mg combination therapy is a more effective
treatment for chronic hepatitis than interferon alfa-2b 3 MIU as a
subcutaneous injection three times a week and 1000 1200mg
ribavirin. The sustained virological response rate in the Pegasys
and Copegus treated patients was 53 percent compared to 44 percent
in the interferon alfa-2b and ribavirin group. The number of
patients who received medication in the study was 1121.
In both studies, virus genotype was clearly the strongest
predictor of whether or not a patient achieved a sustained
virological response.
Pegasys, a premixed solution, is dosed at 180mcg as a
subcutaneous injection once a week. Copegus, available as a 200mg
tablet, is administered at 800 to 1200mg taken twice daily as a
split dose. Pegasys is currently available at pharmacies. Copegus
will be available in early 2003. The two products will be sold
separately.
About Pegasys
Pegasys is supported by the most extensive development program ever
undertaken for a hepatitis C treatment. Pegasys has been studied in
a variety of patient populations, including those with the most
difficult to treat form of the disease patients with genotype 1 and
with cirrhosis (scarring of the liver).
Pegasys is made when interferon alfa-2a undergoes the process of
pegylation in which one or more chains of polyethylene glycol, also
known as PEG, are attached to another molecule. In Pegasys, a
large, branched, mobile PEG is bound to the interferon alfa-2a
molecule and provides a selectively protective barrier.
Pharmacokinetic behavior of the end product depends on the length
of the PEG and the nature of the link between the PEG and the
protein. The high molecular weight (40 kilodalton) branched PEG in
Pegasys has been shown to provide sustained pegylated interferon
alfa2a exposure at clinically effective levels over the one-week
dosing period. Pegasys has been approved for use in more than 50
countries, including all European Union countries.
Pegasys and Copegus Adverse Events
Alpha interferons, including Pegasys, may cause or aggravate fatal
or life-threatening neuropsychiatric, autoimmune, ischemic, and
infectious disorders. Patients should be monitored closely with
periodic clinical and laboratory evaluations. Patients with
persistently severe or worsening signs or symptoms of these
conditions should be withdrawn from therapy. In many, but not all
cases, these disorders resolve after stopping Pegasys therapy.
Copegus may cause birth defects. Extreme care must be taken to
avoid pregnancy in female patients and in female partners of male
patients taking Pegasys and Copegus combination therapy. Ribavirin
causes hemolytic anemia. The anemia associated with ribavirin
therapy may result in worsening of cardiac disease. Ribavirin is
genotoxic, mutagenic, and should be considered a potential
carcinogen. Pegasys is contraindicated in patients with
hypersensitivity to Pegasys or any of its components, autoimmune
hepatitis, and decompensated hepatic disease prior to or during
treatment with Pegasys. Pegasys is also contraindicated in neonates
and infants because it contains benzyl alcohol. Benzyl alcohol has
been reported to be associated with an increased incidence of
neurological and other complications in neonates and infants, which
are sometimes fatal. Pegasys and Copegus therapy is additionally
contraindicated in women who are pregnant, men whose female
partners are pregnant and patients with hemoglobinopathies (eg,
thalassemia major, sickle-cell anemia).
The most common adverse events reported for Pegasys and Copegus
combination therapy, observed in clinical studies to date (n=451),
were fatigue/asthenia (65%), headache (43%), pyrexia (41%), myalgia
(40%), irritability/anxiety/nervousness (33%), insomnia (30%),
alopecia (28%), neutropenia (27%), nausea/vomiting (25%), rigors
(25%), anorexia (24%), injection site reaction (23%), arthralgia
(22%), depression (20%), pruritus (19%) and dermatitis (16%).
Serious adverse events include neuropsychiatric disorders
(suicidal ideation and suicide attempt), serious and severe
bacterial infections, bone marrow toxicity (cytopenia and rarely,
aplastic anemia), cardiovascular disorders (hypertension,
arrhythmias and myocardial infarction), hypersensitivity (including
anaphylaxis), endocrine disorders (including thyroid disorders and
diabetes mellitus), autoimmune disorders (including psoriasis and
lupus), pulmonary disorders dyspnea, pneumonia, brochiolitis
obliterans, interstitial pneumonitis and sarcoidosis), colitis
(ulcerative and hemorrhagic/ischemiccolitis), pancreatitis, and
opthalmologic disorders (decrease or loss of vision, retinopathy
including macular edema and retinal thrombosis/hemorrhages, optic
neuritis and papilledema).
The complete package inserts for Pegasys and Copegus are
available at www.pegasys.com, or by calling 1-877-PEGASYS.
About Hepatitis C
Hepatitis C, a blood-borne infectious disease of the liver, the
leading cause of cirrhosis and liver cancer and the number one
reason for live transplants in the U.S., is transmitted through
body fluids, primarily blood or blood products, and by sharing
needles. In many patients, the mode of transmission is unknown.
Unfortunately, most people infected with hepatitis C are unaware of
it because it may take years for symptoms to develop. Hepatitis C
chronically infects an estimated 170 million people worldwide
(three percent of the world's population), with as many as 180,000
new cases occurring each year. It is estimated that less than 30
percent of all cases are diagnosed. If left untreated, hepatitis C
can be fatal for some patients.
About Roche
Roche Molecular Diagnostics, a business unit of the Roche Group,
manufactures the COBAS AMPLICOR HCV Test, v2.0 test for the
detection of hepatitis C virus in clinical specimens. Hoffmann-La
Roche Inc. (Roche), based in Nutley, N.J., is the U.S. prescription
drug unit of the Roche Group, a leading research-based health care
enterprise that ranks among the world's leaders in pharmaceuticals
and diagnostics. Roche discovers, develops, manufactures and
markets numerous important prescription drugs that enhance people's
health, well-being and quality of life. Among the company's areas
of therapeutic interest are: dermatology; genitourinary disease;
infectious diseases, including influenza; inflammation, including
arthritis and osteoporosis; metabolic diseases, including obesity
and diabetes; neurology; oncology; transplantation; vascular
diseases; and virology, including HIV/AIDS and hepatitis C.
For more information on the Roche pharmaceuticals business in
the United States, visit the company's website at:
http://www.rocheusa.com
Contacts:
Pamela Van Houten, Roche, (973) 562-2231
Hayley Soffer, Manning Selvage & Lee, (212) 213-7067
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