To print: Select File and then Print from your browser's menu --------------------------------------------------------------------------------------- Title: FDA Approves Intron A For Pediatric Use In Chronic Hepatitis B URL: http://www.pslgroup.com/dg/AB66A.htm Doctor's Guide August 25, 1998
MADISON, NJ -- Aug. 25, 1998 -- The United States Food and Drug Administration has approved Schering-Plough Corp.'s Intron(R) A (interferon alfa-2b, recombinant) for injection for the treatment of chronic hepatitis B in pediatric patients one year of age or older. Intron A is the only interferon currently marketed in the U.S. for the treatment of chronic hepatitis B in adults. Chronic hepatitis B is a highly infectious liver disease that can lead to cirrhosis, liver cancer and death. In the U.S., hepatitis B is transmitted through exposure to infected blood and blood products, sexual contact and from infected mothers to their infants. Although there are currently no reliable data on the hepatitis B pediatric population in the U.S., in 1994 approximately 1,200 new cases of hepatitis B were reported in the one to 19-year age group, according to the Centers for Disease Control and Prevention. The benefit of Intron A therapy for pediatric patients with chronic hepatitis B was demonstrated in a controlled study with 149 patients ranging from one year to 17 years of age. In the study, patients treated with Intron A received three million international units (IU)/m2 administered subcutaneously three times a week for one week, then were escalated to six million IU/m2 of Intron A three times a week for a minimum of 16 weeks up to 24 weeks, compared with untreated patients. Treated patients had a significantly better response (24 percent) at 24 weeks of follow up compared with untreated patients (10 percent), as defined by a loss of serum markers (HBV-DNA and HBeAg) that indicate hepatitis viral replication. All but one of the treated responders remained HBV-DNA and HBeAg negative and had a normal serum ALT 12 to 24 months after completion of treatment. Adverse events most frequently reported by patients in this study included flu-like symptoms, gastrointestinal system disorders, nausea and vomiting. The majority of side effects resolved upon dose modification or dose discontinuation. Intron A is a recombinant version of a naturally occurring alpha interferon, having both antiviral and immunomodulatory effects. In addition to chronic hepatitis B, Intron A is marketed in the U.S. for the treatment in adults of chronic hepatitis C, hairy cell leukemia, AIDS-related Kaposi's sarcoma, condylomata acuminata (venereal warts) and as adjuvant therapy for malignant melanoma and in combination with chemotherapy for non-Hodgkin's lymphoma. Intron A is also marketed in the U.S. in combination with Rebetol(R) (ribavirin, USP) Capsules as Rebetron(TM) Combination Therapy. Intron A is marketed in 82 countries for 16 major indications. The most common side effects associated with Intron A therapy are flu-like symptoms, such as fever, headache, myalgia, rigors and asthenia. Other frequently occurring side effects are nausea, alopecia, abdominal pain, depression, musculoskeletal pain and somnolence. As with other interferons, very infrequent reports of suicidal behaviour (ideation, attempts and completed suicides) have been associated with treatment. Related Links: Intron A, Schering-Plough Corp. --------------------------------------------------------------------------------------------- Copyright © 1999 P\S\L Consulting Group Inc. All rights reserved. Republication or redistribution of P\S\L content is expressly prohibited without the prior written consent of P\S\L. P\S\L shall not be liable for any errors, omissions or delays in this content or any other content on its sites, newsletters or other publications, nor for any decisions or actions taken in reliance on such content. --------------------------------------------------------------------------------------------- This news story was printed from *Doctor's Guide to the Internet* located at http://www.docguide.com --------------------------------------------------------------------------------------- Return to News Story Page This site is maintained by webmaster@pslgroup.com Please contact us with any comments, problems or bugs. All contents Copyright (c) 1998 P\S\L Consulting Group Inc. All rights reserved.