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FDA Clears New Treatment Option For Hepatitis C Patients

THOUSAND OAKS, CA. -- October 7, 1997
The U.S. Food and Drug Administration has granted marketing clearance for Amgen's Infergen(R) (Interferon alfacon-1), a bioengineered drug indicated for the treatment of chronic hepatitis C viral (HCV) infection.

The drug has been shown to be safe and effective in HCV patients who have never been treated with previous interferon therapy. In addition, HCV patients who have not responded or who have relapsed after prior treatment with Interferon alpha-2b or Infergen may also benefit from subsequent treatment with Infergen.

Infergen will be Amgen's third product. Infergen is a new-generation, non-naturally occurring recombinant type-1 interferon. The drug is administered three times weekly by subcutaneous injection.

"There is a considerable need for a new hepatitis C therapy because a significant number of HCV patients fail to respond or relapse following treatment," said Donald M. Jensen, M.D., director, section of hepatology, department of medicine, Rush-Presbyterian-St. Luke's Medical Center in Chicago. "Results from the phase III clinical trial indicated Infergen provided an effective first-line therapy for HCV and may benefit patients who have failed previous therapy with Interferon alpha-2b or Infergen."

In a randomized, double-blind study involving 704 patients, Infergen was shown to be an effective and safe option for the initial treatment of HCV. In a phase III clinical study, patients were treated for 24 weeks followed by an additional 24-week observation period.

At the end of the post-treatment observation period, 17 percent of patients who received the optimal dose of Infergen (nine mcg) experienced a sustained normalization of the liver enzyme serumalanine aminotransferase (ALT), a biochemical marker of liver injury; and nine percent experienced a sustained virological response, as measured by serum HCV RNA using a highly-sensitive polymerase chain reaction (PCR) technique.

The safety profile of Infergen was similar to that observed with standard regimens of alfa interferons. The most frequently reported adverse events were flu-like symptoms such as headache, unusual tiredness, fever, muscle aches and stiffness, joint pain and increased sweating. Since the use of type-I interferons have been associated with depression, Infergen therapy should not be used in patients with a history of severe psychiatric disorders and should be discontinued in patients developing severe depression, suicidal ideation or other severe psychiatric disorders. Infergen should be administered with caution to HCV patients with pre-existing cardiac disease.

Until recently, Interferon alfa-2a and -2b were the only approved therapies for the treatment of HCV. A significant percentage of patients who had been treated with interferon therapy either failed to respond to treatment or relapsed.

In a subsequent randomized, controlled clinical trial, 107 hepatitis C patients who failed to respond or who relapsed after prior interferon therapy were treated with a higher dose of Infergen (15 mcg) for 24 weeks and observed for an additional 24 weeks.

Of the Infergen treated patients, 15 percent (16/107) experienced a sustained normalization of ALT concentrations and nine percent (10/107) experienced a sustained virological response as measured by serum HCV RNA. Results from a 48-week subsequent treatment trial with 15 mcg of Infergen have been submitted to and are under review by the FDA.

Researchers at a recent National Institutes of Health Consensus Development Conference on the management of hepatitis C reported nearly four million Americans are currently infected with the virus. Of these, there are up to 180,000 total diagnosed infections per year in the United States, according to the Centers for Disease Control and Prevention.

HCV is four times more common than HIV, the virus that causes AIDS and approximately 8,000 to 10,000 Americans die from HCV each year. In 1991, the last year for which numbers were available, medical and job-related costs from hepatitis C were estimated at $600 million.

Hepatitis C is an insidious and progressive blood-borne virus that can cause liver injury over a period of years and in some cases decades, often without specific symptoms revealing its presence. When they do appear, the infection is usually severe or cirrhosis is present.

Symptoms include loss of appetite, vomiting, stomach pain, fatigue and, in rare cases, jaundice (yellowing of the skin and whites of the eyes). Because the symptoms are common to less-serious conditions, they may often be overlooked or misdiagnosed.

(SOURCE: Doctor's Guide to Medical News, October 7, 1997 - http://www.pslgroup.com)

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