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news.Three Rivers Pharmaceuticals, a company into specialised therapies including hepatitis C therapies, has received expanded labeling from the FDA to include daily use of Infergen (Consensus Interferon) in combination with ribavirin (RBV) for retreatment of chronic hepatitis C patients.
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Three Rivers Pharma said that primary endpoint of increased sustained virological response (SVR) in the clinical trial leading to the expanded labeling, was achieved thereby demonstrating that Infergen provides a second chance for patients to clear their hepatitis C virus.
Three Rivers Pharma stated that the FDA approved the expanded label for Infergen following the data released from the randomised, DIRECT clinical trial (Daily-Dose Consensus Interferon and Ribavirin: Efficacy of Combined Therapy), which showed that the use of Infergen and RBV is a safe and effective retreatment strategy for patients failing initial therapy with PEG-IFN/RBV.
Bruce Bacon, the lead investigator for the registration trial, said: “The FDA’s recognition of this expanded label allows patients failing therapy a safe and efficacious retreatment strategy.”
Patrick Kerrish, president of Three Rivers Pharmaceuticals, said: “The expanded labeling for Infergen is a significant step forward for retreatment of hepatitis C patients who deserve a second chance to overcome their HCV.”