KENILWORTH, N.J. -- Schering-Plough Corporation today reported that the U.S. Food and Drug Administration (FDA) has granted six-month priority review status to its New Drug Application (NDA) for Rebetol (ribavirin, USP) oral solution and capsules. The application seeks FDA approval of Rebetol for use in combination with Intron A (interferon alfa-2b, recombinant) Injection for the treatment of chronic hepatitis C in patients 3 years of age and older with compensated liver disease previously untreated with alpha interferon. Schering-Plough submitted the NDA in January 2003.
Priority review status is granted to drugs that, if approved, would address unmet medical needs and represent significant advances over existing treatments. While it is estimated that less than 200,000 children in the United States are infected with the hepatitis C virus (HCV), new infections in children continue to occur.
"FDA approval of Rebetol for use with Intron A would represent the first and only therapy approved in the United States for treating hepatitis C in the pediatric population," said Robert J. Spiegel, MD, senior vice president of medical affairs and chief medical officer, Schering-Plough Research Institute. "For more than a decade, Schering-Plough has been the leader in advancing treatment of chronic hepatitis C. We are committed to developing innovative therapies to meet the needs of patients with this serious disease."
Rebetol Oral Solution represents a new formulation of ribavirin, USP. Rebetol capsules are currently approved in the United States for use in combination therapy with Intron A for the treatment of chronic hepatitis C in patients with compensated liver disease previously untreated with alpha interferon or who have relapsed following alpha interferon therapy. Rebetol capsules also are indicated in combination with PEG-Intron (peginterferon alfa-2b, recombinant) Injection for the treatment of chronic hepatitis C in patients with compensated liver disease who have not been previously treated with interferon and are at least 18 years of age.
Schering-Plough is committed to supporting hepatitis C patients with education and service programs as well as to help locate financial assistance for patients in need. The company's programs for patients in the United States are among the most comprehensive in the industry, providing support and guidance to patients from the time of diagnosis through treatment, and ensuring that all eligible patients have access to the company's hepatitis C products.
Since the introduction of PEG-Intron and Rebetol combination therapy in 2001, more than 250,000 hepatitis C patients worldwide have received this treatment, including 150,000 patients in the United States. Twenty-five percent of all U.S. patients currently treated with PEG-Intron and Rebetol are enrolled in the company's Commitment to Care program, which provides medication and/or reimbursement assistance to eligible patients. The market value of assistance and treatment provided to hepatitis C patients through this program exceeded $100 million in 2002.
Schering-Plough's Be In Charge hepatitis C patient-support program has enrolled more than 55,000 U.S. patients to date, with more than 25,000 patients enrolling in 2002 alone. This U.S. program is designed to support patients treated with Schering-Plough hepatitis C products through the use of educational materials and telephone contact with personal nurse counselors skilled in the management of hepatitis C.
In a 2002 survey of patients enrolled in the Be In Charge program, overall patient satisfaction was 91 percent, with 75 percent of patients saying that Be In Charge helped them manage their health condition. Of patients surveyed, 96 percent said they would recommend Be In Charge to others. A survey of physicians also reflects their satisfaction with Be In Charge: 83 percent said they would recommend the program to other physicians, 84 percent said they believe patients have a better understanding of their treatment plan because of Be In Charge, and nearly 75 percent of physicians said Be In Charge has reinforced their treatment suggestions to patients.