Peg Intron FDA Approved

It was announced this morning that the FDA approved as monotherapy the first pegylated form of interferon. The Schering Plough product called Peg Intron, which is a powder that will have to be reconstituted with water, was approved for treatment of HCV for infected individuals 18 years & older who have compensated liver disease. The FDA has not yet announced approval of Schering's application to unbundle ribivarin. Schering's announcement of the FDA approval said Peg Intron would be available in early February. So, ribivarin is not yet available for use with Peg Intron, but I think FDA approval for this is near. As you know, pegylated interferon is administered once a week by subcutaneous injection by the patient. Previously, interferon was administered by subcutaneous injections three times per week or every day. The 2nd pegylated interferon is manufactured by Roche and called Pegysus. Roche filed for approval but the FDA has not approved it yet.

Here is the Schering Press Release

First Pegylated Interferon Approved for Marketing in the United States 

KENILWORTH, N.J., Jan. 22 /PRNewswire/ --
Schering-Plough Corporation (NYSE: SGP) today announced that the U.S. Food and Drug Administration (FDA) has approved PEG-INTRON(TM) (peginterferon alfa-2b) Powder for Injection as once-weekly monotherapy for the treatment of chronic hepatitis C in patients not previously treated with alpha interferon who have compensated liver disease and are at least 18 years of age.  PEG-INTRON is the first and only pegylated interferon approved for marketing in the United States.  The product is expected to be available nationwide in early February 2001.

PEG-INTRON is administered subcutaneously once weekly for one year.  The dose should be administered on the same day of each week and may be self-administered by patients.

"Chronic hepatitis C is one of the most prevalent and serious public health problems in the United States," said Richard W. Zahn, president of Schering Laboratories.  "PEG-INTRON offers convenient once weekly dosing that may enhance patient compliance, an important factor in determining optimal clinical outcome," Zahn said.

"While combination therapy with alpha interferon and ribavirin is a recognized standard of care for chronic hepatitis C, PEG-INTRON monotherapy offers an alternative to patients in whom combination therapy may be a contraindication or who are intolerant of this therapy," said John G. McHutchison, M.D., medical director, liver transplantation, division of gastroenterology and hepatology, Scripps Clinic and Research Foundation, La Jolla, Calif.  "As the first pegylated interferon product approved for marketing, PEG-INTRON provides a valuable addition to the therapies available to physicians for treating this serious disease," McHutchison said. The safety and efficacy of PEG-INTRON has been demonstrated in a randomized, controlled clinical study involving 1,219 adult patients with chronic hepatitis C who were not previously treated with alpha interferon. The study compared PEG-INTRON (0.5, 1.0 or 1.5 mcg/kg) administered subcutaneously once weekly to Schering-PloughFs INTRON(R) A (interferon alfa-2b, recombinant) Injection (3 MIU) administered subcutaneously three times weekly.  Patients were treated for 48 weeks and were followed for 24 weeks post-treatment.  In the study, patients receiving the 1.0 mcg/kg dose of PEG-INTRON achieved a 24 percent treatment response rate of sustained virologic response and ALT(1) normalization as compared to a 12 percent treatment response rate in patients receiving INTRON A.  The safety and efficacy of PEG-INTRON in combination with ribavirin have not been established.

Nearly all study patients experienced one or more adverse events. The incidence of serious adverse events was similar (about 12 percent) in all treatment groups. The most common adverse events associated with PEG-INTRON were "flu-like" symptoms, which occurred in approximately 50 percent of patients; injection site irritation or inflammation, seen in 47 percent of patients; and depression, seen in 29 percent of patients.


Alpha interferons, including PEG-INTRON, 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 PEG-INTRON therapy. PEG-INTRON (peginterferon alfa-2b) is a longer-acting form of INTRON A that uses proprietary PEG technology developed by Enzon, Inc. (Nasdaq: ENZN) of Piscataway, N.J.  PEG-INTRON, recombinant interferon alfa-2b linked to a 12,000 dalton polyethylene glycol (PEG) molecule, is a once-weekly product designed to optimize the balance between antiviral activity and elimination half-life.  Schering-Plough holds an exclusive worldwide license to PEG-INTRON.  The company markets the product as PEGINTRON(TM) in the European Union, where it received marketing approval in May 2000.

INTRON A is a recombinant version of naturally occurring alpha interferon, which has been shown to exert both antiviral and immunomodulatory effects. Schering-Plough markets INTRON A, the worldd's largest-selling alpha interferon, for 16 major antiviral and anticancer indications worldwide.

Some 4 million Americans are infected with the hepatitis C virus (HCV) and approximately 70 percent of infected patients go on to develop chronic liver disease, according to the Centers for Disease Control and Prevention (CDC). Hepatitis C infection contributes to the deaths of an estimated 8,000 to 10,000 Americans each year.  This toll is expected to triple by the year 2010 and exceed the number of annual deaths due to AIDS, according to the CDC. The CDC has reported that HCV-associated end-stage liver disease is the most frequent indication for liver transplantation among adults.

Schering Laboratories is the U.S. prescription pharmaceutical marketing arm of Schering-Plough, a research-based company engaged in the discovery, development, manufacturing and marketing of pharmaceutical products worldwide.

(1)ALT:  alanine aminotransferase, an enzyme that indicates ongoing liver inflammation.

SOURCE  Schering-Plough Corporation