November 25, 2009
BLA submitted for Zalbin, a treatment for chronic hepatitis C (HCV)Human Genome Sciences announced that it has submitted a Biologics License Application (BLA) to the FDA for Zalbin (albinterferon alfa-2b) for the treatment of chronic hepatitis C (HCV). The BLA submission includes the results of two pivotal Phase 3 clinical trials, known as ACHIEVE 1 and ACHIEVE 2/3, showing that 900-mcg albinterferon alfa-2b dosed every two weeks met its primary endpoint of non-inferiority to peginterferon alfa-2a (Pegasys) dosed once weekly. In both studies, albinterferon alfa-2b, with half the injections, achieved sustained virologic response comparable to that achieved by peginterferon alfa-2a. ACHIEVE 1 was conducted in patients infected with genotype 1 virus, and ACHIEVE 2/3 was conducted in patients with genotypes 2 or 3 virus. The two studies treated a total of 2255 patients.
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.
For more information call (877) 822-8472 or visit www.hgsi.com.