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Human Genome Sciences Announces FDA Is Unlikely to Approve Albumin Interferon Once Every 2 Weeks

SUMMARY: Human Genome Sciences announced last week that the U.S. Food and Drug Administration (FDA) has provided preliminary feedback indicating that it probably will not grant the company's request for approval of albumin interferon alfa-2b (Zalbin in the U.S., Joulferon in Europe) administered once every 2 weeks. In April, the European Union regulatory agency also declined to approve this dosing regimen.

The ACHIEVE-1 study found that albumin interferon at 900 mcg every 2 weeks was statistically non-inferior to standard therapy using once-weekly pegylated interferon (both with ribavirin) in people with HCV genotype 1, and a Phase 2b study recently showed that once monthly albumin interferon worked as well as pegylated interferon for those with genotypes 2 or 3.

The FDA expressed concern, however, that albumin interferon's risk/benefit ratio was not sufficiently favorable, considering its lower potency with less frequent dosing and its potential for serious respiratory side effects.

Below is an excerpt from a recent Human Genome Sciences press release summarizing the FDA's feedback.

Human Genome Sciences Announces Preliminary Feedback
from FDA on Zalbin BLA for Chronic Hepatitis C

Rockville, Maryland -- June 14, 2010 -- Human Genome Sciences, Inc. (Nasdaq: HGSI) today announced that it has received preliminary written feedback from the U.S. Food and Drug Administration (FDA) regarding the Company's Biologics License Application (BLA) seeking approval in the United States to market 900-mcg Zalbin (albinterferon alfa-2b, known in Europe as Joulferon) dosed every two weeks for the treatment of chronic hepatitis C. FDA has expressed concerns regarding the risk benefit assessment of ZALBIN dosed at 900-mcg every two weeks. Although the BLA review is ongoing, HGS has concluded that licensure of this dosing regimen is unlikely.

The FDA feedback was provided via a Discipline Review letter, which is a standard vehicle for review disciplines (e.g., clinical) to convey early thoughts on possible deficiencies of an application. In April 2010, HGS announced that Novartis withdrew its Marketing Authorization Application for Joulferon from the European Medicines Agency.

Zalbin (Joulferon) is being developed by HGS and Novartis under an exclusive worldwide co-development and commercialization agreement entered into in 2006. HGS and Novartis are considering development of Zalbin dosed every four weeks, and HGS previously reported the positive interim results of a Phase 2b study of this Zalbin regimen.

About Zalbin (albinterferon alfa-2b)


Zalbin (also known as Joulferon) is a genetic fusion of human albumin and interferon alfa created using proprietary HGS albumin-fusion technology. Human albumin is the most prevalent naturally occurring blood protein in the human circulatory system, persisting in circulation in the body for approximately 19 days. Research has shown that genetic fusion of therapeutic proteins to human albumin decreases clearance and prolongs the half-life of the therapeutic proteins.

About Human Genome Sciences

The mission of HGS is to apply great science and great medicine to bring innovative drugs to patients with unmet medical needs.

For more information about HGS, please visit the Company's web site at www.hgsi.com. Health professionals and patients interested in clinical trials of HGS products may inquire via e-mail to medinfo@hgsi.comor by calling HGS at (877) 822-8472.

6/22/10

Source
Human Genome Sciences. Human Genome Sciences Announces Preliminary Feedback from FDA on Zalbin BLA for Chronic Hepatitis C. Press release. June 14, 2010.

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 


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