AND ANOTHER ANNOUNCEMENT:
NUTLEY, N.J. (October 16XX, 2002) – Roche announced today that the U.S. Food and Drug Administration (FDA) has approved PegasysŇ (peginterferon alfa-2a) for the treatment of adults with chronic hepatitis C who have compensated liver disease and have not previously been treated with interferon alpha. Patients in whom efficacy was demonstrated included patients with compensated cirrhosis.
Pegasys is a pegylated interferon that remains active in the bloodstream longer and at a more constant level than interferon alpha. Currently, 2.7 million Americans are chronically infected with hepatitis C.
“The approval of Pegasys is an important milestone for the hepatitis C patients in the United States who are waiting for treatment,” said George B. Abercrombie, President and Chief Executive Officer, Hoffmann-La Roche Inc. “Roche has supported Pegasys with the most extensive development program ever undertaken for a hepatitis C treatment. The result is that patients and physicians have an important new option for treatment.”
Pegasys was granted approval based on the results of three pivotal Phase III clinical trials that demonstrated it is an effective treatment for patients with chronic hepatitis C, including cirrhotic patients with compensated liver disease, versus treatment with Roferon-A® (interferon alfa-2a). Two of these pivotal trials were published in The New England Journal of Medicine.
The sustained virological response rate in the Pegasys treated patients was as high as 38 percent in the overall population versus 19 percent in the interferon alfa-2a group. The sustained virological response in patients with cirrhosis treated with Pegasys was as high as 30 percent versus 8 percent in the interferon alfa-2a group. Higher sustained virological response results 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 defined as undetectable serum hepatitis C RNA levels post-treatment (on or after study week 68).
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 at Rush-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 therapy. This may help patients adhere to therapy that can be difficult on them, particularly during the first few months.”
12-Week Sample Program for Up to 15,000 Patients
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 n Pegasys therapy prior to December 31, 2002. Twelve weeks was selected because at that point physicians can predict those patients who will not respond to Pegasys therapy. Samples are available to all physicians.
Pegasys, available as a premixed solution, is expected to be in pharmacies within two weeks. Pegasys is dosed at 180 ?g as a subcutaneous injection once a week for a recommended duration of 48 weeks.
Pegasys is supported by the most extensive development program ever undertaken for a hepatitis C treatment. The FDA has granted Pegasys in combination with Copegus® (Roche ribavirin) priority review status, and a decision is expected by the end of 2002. The FDA grants priority review status to products that, if approved, are expected to offer a significant improvement over existing therapies in the safety or effectiveness of the treatment, diagnosis or prevention of a serious or life-threatening disease.
Pegasys has been studied in a variety of patient populations, including those with the most difficult to treat form of the disease – patients with genotype 1 and with cirrhosis (scarring of the liver).
Pegasys 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 interferon alfa-2a molecule and provides a selectively protective barrier. Pharmacokinetic 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 sustained
pegylated interferon alfa–2a exposure at clinically effective levels over the one-week dosing period.
In contrast, interferons with smaller PEGs are excreted more rapidly by the kidneys, requiring more frequent dosing, according to earlier Roche studies, using smaller PEGs developed by the company.
Pegasys has been approved for use in 50 countries, including all European Union countries.
Pegasys Adverse Events
Alpha interferons, including Pegasys, may 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 Pegasys therapy.
Pegasys is contraindicated in patients with hypersensitivity to Pegasys or any of its components, autoimmune hepatitis, and decompensated hepatic disease prior to or during treatment with Pegasys. Pegasys is also contraindicated in neonates and infants because it contains benzyl alcohol. Benzyl alcohol has been reported to be associated with an increased incidence of neurological and other complications in neonates and infants which are sometimes fatal.
The most common adverse events reported for Pegasys, observed in clinical studies to date, were headache, fatigue, myalagia, pyrexia, rigors, arthralgia, nausea, alopecia, injection-site reaction, neutropenia, insomnia, depression, anorexia, and irritability.
Other serious adverse events include bone marrow toxicity, cardiovascular disorders, hypersensitivity, endocrine disorders, pulmonary disorders, 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 leading cause of cirrhosis and liver cancer and the number one reason for liver transplants in the U.S., is transmitted through body fluids, primarily blood or blood products, and by sharing needles. In many patients, the mode of transmission is unknown. Unfortunately, most people infected with hepatitis C are unaware of it because it may take years for symptoms to develop. Hepatitis C chronically infects an estimated 170 million people worldwide (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 some patients.
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: http://www.rocheusa.com
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