Published on December 15, 2009 at 7:51 AM
Human Genome Sciences, Inc. (Nasdaq: HGSI) today announced that Novartis
has submitted a Marketing Authorization Application (MAA) to the
European Medicines Agency (EMEA) for approval to market JOULFERON®
(albinterferon alfa-2b, known in the United States as ZALBIN™) for the
treatment of chronic hepatitis C. In November 2009, HGS submitted a
Biologics License Application (BLA) for ZALBIN to the FDA in the United
States.
The MAA submission includes the results of two pivotal Phase 3 clinical
trials 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 each week. The Phase 3 studies, known as ACHIEVE 1
and ACHIEVE 2/3, evaluated albinterferon alfa-2b vs. peginterferon
alfa-2a, in combination with ribavirin, for use in the treatment of
interferon-naïve patients with chronic hepatitis C. In both studies,
albinterferon alfa-2b, with half the injections, achieved sustained
virologic response comparable to that achieved by peginterferon alfa-2a.
The rates of serious and/or severe adverse events were also comparable
in these studies. 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.
“Assuming licensure by the EMEA and other regulatory agencies, HGS
believes JOULFERON could become an important treatment for chronic
hepatitis C,” said H. Thomas Watkins, President and Chief Executive
Officer, HGS. “We look forward to continuing to work closely with
Novartis to advance albinterferon alfa-2b to the market under the brand
name ZALBIN in the United States.”
SOURCE Human Genome Sciences, Inc.
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Posted in: Medical Condition News | Pharmaceutical News
Tags: Anthrax, Antibody, Apoptosis, Cancer, Cirrhosis, Coronary Heart Disease, Diabetes, Hepatitis A, Hepatitis C, Hepatitis E, Liver Cancer, Lupus, Peginterferon alfa, Ribavirin, Type 2 Diabetes, Virus