icon star paper   Articles  
Back grey_arrow_rt.gif
FDA Approves Pegasys Monotherapy Today
reported by Jules Levin
  Today October 16, the FDA approved Pegasys, pegylated interferon Roche brand, as monotherapy for treating Hepatitis C, and announced it tonite at 6:30pm. The FDA is currently reviewing the Roche application for combination therapy of Pegasys + ribavirin and approval for the combination is expected in December. Ribavirin and Pegasys will be available to be purchased separately. Pegasys will be available for purchase soon in the pharmacy. Roche announced today a program making Pegasys available for free for 12 weeks to up to 15,000 individuals, and this program is described below. Doctors can call on Monday 1-877-Pegasys to get information about this program and regarding followup access to Pegasys after the 12-week program. The free drug will available on a first come first served basis, so if you would like to acquire drug through this program your doctor should call immediately. Roche announced that starting Monday October 21 the Pegasys reimbursement assistance program, Pegassist, will be up and running by Monday to assist patients with coverage or access through Roche.
To read about the two Pegasys+ribavirin studies in HCV-monoinfected patients and the results which will be reviewed by the FDA for approval of the combination, here is the link to NATAP reports:
Pegasys + Ribavirin: 24 vs 48 weeks; 800 vs 1000/1200 ribavirin (April 2002)
Pegasys + Ribavirin: study results published in New England Journal of Medicine (Sept 2002)
Press Release From Roche
FDA Approves Pegasys (peginterferon alfa-2a)
For the Treatment of Hepatitis C
Roche sample program to provide first 12 weeks of Pegasys at no cost for up to 15,000 patients
NUTLEY, N.J. (October 16, 2002) - Roche announced today that the U.S. Food and Drug Administration (FDA) has approved Pegasys" (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 on 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 ug 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.
About Pegasys
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.
  icon paper stack View Older Articles   Back to Top   www.natap.org