By Jennifer Booton
Published October 05, 2010
Human Genome Sciences (HGSI: 30.12 ,+0.65 ,+2.21%) and partner Novartis (NVS: 57.74 ,+0.72 ,+1.26%) have terminated development of their Zalbin drug studied as a potential treatment for chronic hepatitis C.
Development was halted after Rockville, Maryland-based Human Genome received a “complete response letter” from the Food and Drug Administration, often seen as a request for more information regarding a drug application.
The company had a Biologics License Application for 900-mcg Zalbin dosed every two weeks.
In May, the company had said it did not expect to achieve FDA approval at its current dosage.
That view followed a “discipline review letter” in which the FDA voiced safety concerns about the specific dosage.