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Janssen gets speedy review for Hep C drug

Daily News | May 14, 2013

Selina McKee

Janssen gets speedy review for Hep C drug

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.

Approximately 150 million people worldwide are chronically infected with hepatitis C, and 350,000 people per year die from the disease. While the condition can be cured, around 60% of patients do not achieve viral cure after treatment with 48 weeks of standard therapy with pegylated-interferon and ribavirin alone, highlighting the room for new treatments.

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