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  AIDS 2002 Barcelona
Barcelona, Spain July 7-12 2002
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Reported by Jules Levin
  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 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, CA.
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.
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 at: www.rocheusa.com.