FDA GRANTS PRIORITY REVIEW TO PEGASYS (peginterferon alfa-2a) AND RIBAVIRIN
COMBINATION FOR TREATMENT OF HEPATITIS C
Reported by Jules Levin
Priority review designation granted to therapies that address unmet medical
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 PEGASYS (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.
"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.
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,
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
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.
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.
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
For more information on the Roche pharmaceuticals business in the United
States, visit the company's website at: www.rocheusa.com.