FDA may not approve Human Genome hepatitis C drug
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Human Genome Sciences Inc (HGSI.O) said it is unlikely for the Food and Drug Administration to approve its anti-hepatitis C medication at the indicated dose.
The company made such a comment after it received a discipline review letter from the U.S. drug regulator, which shows the agency's concern about the risk/benefit assessment of the drug called Zalbin at a dose of 900 micro-grams every 2 weeks.
The FDA is still reviewing the case and has not rejected the application, but Human Genome was cited as saying in a statement that it is unlikely that Zalbin would have any chance of getting approved.
In April, Novartis AG, Human Genome's partner, withdrew its application for the drug submitted to the the European regulator after the agency said data submitted were not sufficient.
Hepatitis C is a highly risky liver disease that can lead to chronic hepatitis C infection, chronic liver disease, cirrhosis or liver cancer or dying.
An estimated 75 to 85 percent of people infected with hepatitis C virus go on to develop chronic ingestion and 1 to 5 percent will die from the infection.
JD
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