Drug maker Human Genome Sciences Inc., (HGSI) , Tuesday revealed the submission of a Marketing Authorization Application with the European Medicines Agency by Novartis (NVS), for approval to market Joulferon - albinterferon alfa-2b, indicated in the treatment of chronic hepatitis C patients. The drug is known in the United States as Zalbin with Human Genome having made a Biologics License Application with the FDA in the United States last month.
Human Genome has primary responsibility for the bulk production of albinterferon alfa-2b, and Novartis will have responsibility for commercial manufacturing of the finished drug product.
Hepatitis C is an inflammation of the liver caused by the hepatitis C virus. It is estimated that about 170 million people worldwide are infected with hepatitis C virus. This includes nearly four million people in the United States.
The Marketing Authorization Application submission includes the results of two pivotal Phase 3 clinical trials that showed 900-mcg albinterferon alfa-2b dosed every two weeks met its primary endpoint of non-inferiority to peginterferon alfa-2a dosed once each week.
The Phase 3 studies, known as ACHIEVE 1 and ACHIEVE 2/3, evaluated albinterferon alfa-2b versus 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.
HGSI is trading at $28.57, up $0.02 or 0.07%, on a volume of 1.09 million shares on the Nasdaq. NVS is trading at $53.80, down $0.41 or 0.76%, on the NYSE.
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