(more info on PEG at bottom of page)
News Article: Schering-Plough Announces FDA Approval of
Peg-Intron(TM) For Treatment of Chronic Hepatitis C
KENILWORTH, N.J., Jan. 22 /PRNewswire/ -- Schering-Plough
Corporation (NYSE:SGP)
today announced that the U.S. Food and Drug Administration (FDA)
has approved PEG-INTRON(TM) (peginterferon alfa-2b) Powder for
Injection as once-weekly monotherapy for the treatment of chronic
hepatitis C in patients not previously treated with alpha
interferon who have compensated liver disease and are at least 18
years of age. PEG-INTRON is the first and only pegylated interferon
approved for marketing in the United States. The product is
expected to be available nationwide in early February 2001.
PEG-INTRON is administered subcutaneously once weekly for one year.
The dose should be administered on the same day of each week and
may be self-administered by patients.
"Chronic hepatitis C is one of the most prevalent and serious
public health problems in the United States," said Richard W. Zahn,
president of Schering Laboratories. "PEG-INTRON offers convenient
once weekly dosing that may enhance patient compliance, an
important factor in determining optimal clinical outcome," Zahn
said.
"While combination therapy with alpha interferon and ribavirin is a
recognized standard of care for chronic hepatitis C, PEG-INTRON
monotherapy offers an alternative to patients in whom combination
therapy may be a contraindication or who are intolerant of this
therapy," said John G. McHutchison, M.D., medical director, liver
transplantation, division of gastroenterology and hepatology,
Scripps Clinic and Research Foundation, La Jolla, Calif. "As the
first pegylated interferon product approved for marketing,
PEG-INTRON provides a valuable addition to the therapies available
to physicians for treating this serious disease," McHutchison
said.
The safety and efficacy of PEG-INTRON has been demonstrated in a
randomized, controlled clinical study involving 1,219 adult
patients with chronic hepatitis C who were not previously treated
with alpha interferon. The study compared PEG-INTRON (0.5, 1.0 or
1.5 mcg/kg) administered subcutaneously once weekly to
Schering-PloughFs INTRON(R) A (interferon alfa-2b, recombinant)
Injection (3 MIU) administered subcutaneously three times weekly.
Patients were treated for 48 weeks and were followed for 24 weeks
post-treatment. In the study, patients receiving the 1.0 mcg/kg
dose of PEG-INTRON achieved a 24 percent treatment response rate of
sustained virologic response and ALT(1) normalization as compared
to a 12 percent treatment response rate in patients receiving
INTRON A. The safety and efficacy of PEG-INTRON in combination with
ribavirin have not been established.
Nearly all study patients experienced one or more adverse events.
The incidence of serious adverse events was similar (about 12
percent) in all treatment groups. The most common adverse events
associated with PEG-INTRON were "flu-like" symptoms, which occurred
in approximately 50 percent of patients; injection site irritation
or inflammation, seen in 47 percent of patients; and depression,
seen in 29 percent of patients.
WARNING: Alpha interferons, including PEG-INTRON, 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 PEG-INTRON therapy.
PEG-INTRON (peginterferon alfa-2b) is a longer-acting form of
INTRON A that uses proprietary PEG technology developed by Enzon,
Inc. (NASDAQ
:ENZN) of Piscataway, N.J. PEG-INTRON, recombinant interferon
alfa-2b linked to a 12,000 dalton polyethylene glycol (PEG)
molecule, is a once-weekly product designed to optimize the balance
between antiviral activity and elimination half-life.
Schering-Plough holds an exclusive worldwide license to PEG-INTRON.
The company markets the product as PEGINTRON(TM) in the European
Union, where it received marketing approval in May 2000. INTRON A
is a recombinant version of naturally occurring alpha interferon,
which has been shown to exert both antiviral and immunomodulatory
effects. Schering-Plough markets INTRON A, the worldFs
largest-selling alpha interferon, for 16 major antiviral and
anticancer indications worldwide. Some 4 million Americans are
infected with the hepatitis C virus (HCV) and approximately 70
percent of infected patients go on to develop chronic liver
disease, according to the Centers for Disease Control and
Prevention (CDC). Hepatitis C infection contributes to the deaths
of an estimated 8,000 to 10,000 Americans each year. This toll is
expected to triple by the year 2010 and exceed the number of annual
deaths due to AIDS, according to the CDC. The CDC has reported that
HCV-associated end-stage liver disease is the most frequent
indication for liver transplantation among adults.
Schering Laboratories is the U.S. prescription pharmaceutical
marketing arm of Schering-Plough, a research-based company engaged
in the discovery, development, manufacturing and marketing of
pharmaceutical products worldwide.
(1)ALT: alanine aminotransferase, an enzyme that indicates ongoing
liver inflammation.
For historical info about Pegylated Interferon, click on the
links below:
PEG interferon and ribavirin reduce
liver fibrosis rate in hepatitis C
Modified Interferon Effective Against
Hepatitis C
Peginterferon Alfa-2a in Patients
with HCV and Cirrhosis
PEG / Maintenance interferon therapy
for nonresponder
Study Data on PEG
Pegasys Shows Efficacy In Chronic
HCV Patients With Cirrhosis
PEG-Intron A - Longer Lasting
Interferon
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