Genome Sciences Announces FDA Is Unlikely to Approve Albumin Interferon
Once Every 2 Weeks
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.
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.
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
is an excerpt from a recent Human Genome Sciences press release
summarizing the FDA's feedback.
Genome Sciences Announces Preliminary Feedback
from FDA on Zalbin BLA for Chronic Hepatitis C
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
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
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
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 email@example.com
by calling HGS at (877) 822-8472.
Human Genome Sciences. Human Genome Sciences Announces Preliminary
Feedback from FDA on Zalbin BLA for Chronic Hepatitis C. Press
release. June 14, 2010.