Janssen gets speedy review for Hep C drug

New Drug Approvals

simeprevir

US regulators have agreed to conduct an accelerated review of Janssen Research & Development’s investigational hepatitis C drug simeprevir.

The product, which is under review as a combination treatment for genotype 1 hepatitis C in adult patients with compensated liver disease, is an investigational NS3/4A protease inhibitor administered as a 150mg capsule once daily alongside pegylated interferon and ribavirin. 

The US Food and Drug Administration grants Priority Review to medicines that potentially offer major advances where no adequate therapies exists, and aims to complete its assessment within six months. As such, Janssen said it expects a decision by November this year. 

Simeprevir is also currently being assessed by regulators in Europe and Japan.

 

Simeprevir (formerly TMC435) is an experimental drug candidate for the treatment of hepatitis C. It is being developed by Medivir and Johnson & Johnson’s pharmaceutical division Janssen Pharmaceutica and is currently in Phase III clinical…

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