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Board Index > Hepatitis | 0-9 A B C D E F G H I J K L M N O P Q R S T U V W X Y Z


Re: New treatment
Aug 5, 2002
Cudagirl, here is LOST1's post on Pegasys.

I will be one of the first in line for Pegasys- this is my personnal choice, only one injection a week, a much stronger affective med with fewer "sides".and a 70% chance of success, far surrpassing present meds for us geno 1A's.
Check out the HVC related deaths by 2010, overtaking HIV-----scary

sorry I had to ### out the adresss, but scout around, it can be found.


FDA GRANTS PRIORITY REVIEW TO PEGASYSŪ (peginterferon alfa-2a) AND RIBAVIRIN
COMBINATION FOR TREATMENT OF HEPATITIS C Priority review designation granted
to therapies that address unmet medical needs Nutley, NJ - July 15, 2002 -
The U.S. Food and Drug Administration (FDA) has granted a six-month Priority
Review Status to the Biologics License Application (BLA) and New Drug
Application (NDA) for Roche's combination therapy of PEGASYSŪ (peginterferon
alfa-2a) and Roche ribavirin tablets, for the treatment of chronic hepatitis
C in patients without cirrhosis and with cirrhosis with compensated liver
disease. Roche submitted this file with the FDA in June, 2002 and approval
action is expected by the end of the year.
Priority designation is granted to biologics and drugs that if approved,
must address unmet medical needs, offering a significant improvement in the
safety or effectiveness of the treatment, diagnosis or prevention of a
serious or life-threatening disease, according to FDA policies and
procedures.
-more-
"With the expected approval, PEGASYS will be an important new therapy for
patients," said Georges Gemayel, Vice President, National Specialty Care
Business Operation, at Roche. "We are very proud of our ongoing commitment
to the hepatitis C market. Roche has invested in clinical trials to answer
key questions about hepatitis C treatment and we will continue to do so."
The PEGASYS combination filing is based on two large pivotal studies
conducted with more than 2,400 patients. Data filed with the FDA include
findings from a study evaluating the treatment duration and dose of
ribavirin for patients with genotype 1 and non-1 hepatitis C.
The PEGASYS combination filing also includes data regarding predictability
of a patient's response at week 12 to PEGASYS combination therapy.
About PEGASYS PEGASYS is supported by the most extensive development program
ever undertaken for a hepatitis C treatment, having been studied in nearly
20,000 patients ranging from those with the most difficult to treat form of
the disease (genotype 1) and those with cirrhosis (scarring of the liver),
to other special populations, such as in individuals co-infected with HIV
and patients with end-stage renal disease.
PEGASYS is a ready-to-use solution for once weekly injection. The
pharmacokinetic data show that weekly subcutaneous injections of PEGASYS
maintain therapeutic concentrations throughout the week.
PEGASYS is composed of a high molecular weight (40 kilodalton) branched
polyethylene glycol (PEG) molecule linked to interferon alpha-2a. Roche
evaluated high and low weight branched and linear PEGs in the development of
PEGASYS. The PEG used in PEGASYS was licensed by Roche from Shearwater
Corporation, a subsidiary of Inhale Therapeutic Systems, Inc. in San Carlos,
CA.
-more-

In June, PEGASYS monotherapy and combination therapy were granted marketing
authorization by the European Commission, making it immediately available in
all European Union countries and paving the way for approvals in Central and
Eastern European countries. PEGASYS has been approved for use in 25
countries since its first approval in Switzerland in August 2001. It is now
available in Argentina, Brazil, Bahrain, Belarus, Cambodia, Chile, Columbia,
Costa Rica, Dominican Republic, Ecuador, Egypt, El Salvador, Guatemala,
Israel, Kuwait, Mexico, Morocco, Panama, Peru, Russia, Syria, United Arab
Emirates, Uruguay and Venezuela.
PEGASYS Adverse Events The most common serious adverse events reported for
PEGASYS, observed in clinical studies to date, were infections, psychiatric
disorders and gastrointestinal disorders. The most common adverse events
for combination therapy included flu-like symptoms, such as fever, chills,
fatigue, headache, myalgia/arthralgia, nausea/vomiting, anorexia, diarrhea
and abdominal pain, injection site reactions, partial alopecia, depression,
irritability, insomnia and dizziness. Severe psychiatric adverse events
have occurred during treatment with PEGASYS, combination
interferon/ribavirin, or interferon alone therapy both in patients with and
without a previous psychiatric disorder.
In addition, ribavirin has its own adverse events, the most serious of which
are birth defects. For this reason, ribavirin and interferon with ribavirin
must not be used by women or male partners of women who intend to become
pregnant during therapy or within six months of therapy. Ribavirin has been
shown to cause anemia in some patients, which may exacerbate previous
coronary heart disease, or deteriorate heart function.

-more-

About Hepatitis C Hepatitis C is a blood-borne virus transmitted through
body fluids, primarily blood or blood products, and sharing needles. In
many patients, the mode of transmission is unknown.
Unfortunately, most people who are infected with hepatitis C are unaware of
it because it may take years for symptoms to develop.
Hepatitis C is a leading cause of cirrhosis and liver cancer and the
number-one reason for liver transplants in the U.S. An estimated 2.7
million Americans are chronically infected with the virus, with
approximately 35,000 new infections each year.
In the United States, the Centers for Disease Control and Prevention
estimate that hepatitis C is responsible for eight to ten thousand deaths
per year and could increase to 38,000 by the year 2010, surpassing annual
HIV/AIDS deaths.
About Roche 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, diagnostics and vitamins. 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





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