Human Genome Sciences has submitted a Biologics License Application (BLA) to the FDA for Zalbin (albinterferon alfa-2b) for the treatment of chronic hepatitis C. The BLA submission includes the results of two pivotal Phase 3 clinical trials showing that 900mcg 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-naive 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.
H Thomas Watkins, president and chief executive officer of HGS, said: “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.
“Assuming licensure by the FDA and other regulatory agencies, HGS believes Zalbin could become an important treatment for chronic hepatitis C. Novartis targets submission of marketing authorization applications under the brand name joulferon in the rest of the world later this quarter, beginning with Europe.”