Roche Sample Program to Provide First 12 Weeks of Pegasys at No
For Up to 15,000 Patients
NUTLEY, N.J., Oct. 16 /PRNewswire/ -- Roche announced today that
Food and Drug Administration (FDA) has approved Pegasys(R) (peginterferon
alfa-2a) for the treatment of adults with chronic hepatitis C
compensated liver disease and have not previously been treated
alpha. Patients in whom efficacy was demonstrated included
Pegasys is a pegylated interferon that remains active in the
longer and at a more constant level than interferon alpha.
million Americans are chronically infected with hepatitis C.
"The approval of Pegasys is an important milestone for the
patients in the United States who are waiting for
treatment," said George B.
Abercrombie, President and Chief Executive Officer, Hoffmann-La
"Roche has supported Pegasys with the most extensive
development program ever
undertaken for a hepatitis C treatment. The result is that
physicians have an important new option for treatment."
Pegasys was granted approval based on the results of three
III clinical trials that demonstrated it is an effective
patients with chronic hepatitis C, including cirrhotic patients
compensated liver disease, versus treatment with Roferon-A(R)
alfa-2a). Two of these pivotal trials were published in The New
Journal of Medicine.
The sustained virological response rate in the Pegasys treated
was as high as 38 percent in the overall population versus 19
percent in the
interferon alfa-2a group.
The sustained virological response in
cirrhosis treated with Pegasys was as high as 30 percent versus
8 percent in
the interferon alfa-2a group. Higher sustained virological
were also found in patients with genotype 1, on Pegasys
treatment (23 percent)
versus interferon alfa-2a (6 percent), the most common type in
the U.S. and
most difficult to treat. Sustained virological response was
undetectable serum hepatitis C RNA levels post-treatment (on or
Clinical trials of Pegasys have shown that patients can
determine at 12
weeks if they are unlikely to attain a sustained virological
response with Pegasys.
Pegasys investigator, Donald Jensen, MD, director of Hepatology
Presbyterian-St. Luke's Medical Center, Chicago said, "With Pegasys, we can
determine at week 12 of therapy those patients who are unlikely
to achieve a
sustained virological response to treatment. This reduces the
cost and burden
of taking therapy for patients who are unlikely to respond to
may help patients adhere to therapy that can be difficult on
particularly during the first few months."
As part of Roche's commitment to treating patients with
hepatitis C, Roche
will be providing physicians with samples of Pegasys for the
first 12 weeks of
therapy. These samples will be provided at the request of a
physician for the
first 15,000 patients who are started on Pegasys therapy prior
to December 31,
2002. Twelve weeks was selected because at that point physicians
those patients who will not respond to Pegasys therapy. Samples
to all physicians.
Pegasys, available as a premixed solution, is expected to be in
within two weeks. Pegasys is dosed at 180 ug as a subcutaneous
a week for a recommended duration of 48 weeks.
Pegasys is supported by the most extensive development program
undertaken for a hepatitis C treatment. The FDA has granted
combination with Copegus(R) (Roche ribavirin) priority review
status, and a
decision is expected by the end of 2002. The FDA grants priority
status to products that, if approved, are expected to offer a
improvement over existing therapies in the safety or
effectiveness of the
treatment, diagnosis or prevention of a serious or
Pegasys has been studied in a variety of patient populations,
those with the most difficult to treat form of the disease --
genotype 1 and with cirrhosis (scarring of the liver). P
egasys 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
2a molecule and provides a selectively protective barrier.
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
pegylated interferon alfa-2a exposure at clinically effective
levels over the
one-week dosing period.
In contrast, interferons with smaller PEGs are excreted more
the kidneys, requiring more frequent dosing, according to
studies, using smaller PEGs developed by the company.
Pegasys has been approved for use in 50 countries, including all
Pegasys Adverse Events
Alpha interferons, including Pegasys, may cause or aggravate
life-threatening neuropsychiatric, autoimmune, ischemic, and
disorders. Patients should be monitored closely with periodic
laboratory evaluations. Patients with persistently severe or
or symptoms of these conditions should be withdrawn from
therapy. In many,
but not all cases, these disorders resolve after stopping
Pegasys is contraindicated in patients with hypersensitivity to
any of its components, autoimmune hepatitis, and decompensated
prior to or during treatment with Pegasys. Pegasys is also
neonates and infants because it contains benzyl alcohol. Benzyl
been reported to be associated with an increased incidence of
other complications in neonates and infants which are sometimes
The most common adverse events reported for Pegasys, observed in
studies to date, were headache, fatigue, myalagia, pyrexia,
rigors, arthralgia, nausea, alope cia, injection-site reaction, neutropenia, insomnia,
depression, anorexia, and irritability.
Other serious adverse events include bone marrow toxicity,
disorders, hypersensitivity, endocrine disorders, pulmonary
colitis, pancreatitis, and ophthalmologic disorders.
The complete package insert is available upon request.
About Hepatitis C
Hepatitis C, a blood-borne infectious disease of the liver, the
cause of cirrhosis and liver cancer and the number one reason
transplants in the U.S., is transmitted through body fluids,
or blood products, and by sharing needles. In many patients, the
transmission is unknown. Unfortunately, most people infected
with hepatitis C
are unaware of it because it may take years for symptoms to
Hepatitis C chronically infects an estimated 170 million people
(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
Hoffmann-La Roche Inc. (Roche), based in Nutley, N.J., is the
prescription drug unit of the Roche Group, a leading
care enterprise that ranks among the world's leaders in
diagnostics and vitamins. Roche discovers, develops,
manufactures and markets
numerous important prescription drugs that enhance people's
and quality of life. Among the company's areas of therapeutic
dermatology; genitourinary disease; infectious diseases,
inflammation, including arthritis and osteoporosis; metabolic
including obesity and diabetes; neurology; oncology;
diseases; and virology, including HIV/AIDS and hepatitis C.
For more information on the Roche pharmaceuticals business in
States, visit the company's website at: http://www.rocheusa.com