FDAnews Drug Daily Bulletin
Pharmaceuticals / Regulatory Affairs / Submissions and Approvals

EMA Promises Swift Review of BI’s Next-Generation Hep C Drug

Nov. 27, 2013
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The European Medicines Agency (EMA) has put Boehringer Ingelheim’s hepatitis C drug candidate faldaprevir on a speedy review pathway based on studies involving 3,300 patients.

If approved, the drug could be available on EU shelves early next year, the drugmaker says.

Once-daily faldaprevir is proposed as a treatment for patients with genotype 1 hepatitis C, including those with HIV co-infection or advanced liver disease, in combination with ribavirin and pegylated interferon. Supporting studies found, among other things, that a majority of treatment-naïve participants benefited from shorter treatment duration and achieved viral cure.

Boehringer Ingelheim is also studying the drug as an interferon-free treatment, jumping into a race involving a number of other large drugmakers. Tuesday’s announcement about faldaprevir comes after two other next-generation hepatitis C drugs cleared key regulatory hurdles on Friday.

The FDA approved Janssen and Medivir’s Olysio (simeprevir), an NS3/4A protease inhibitor. And the EMA’s Committee for Medicinal Products for Human Use recommended marketing authorization for Sovaldi (sofosbuvir), Gilead’s Hep C drug candidate proposed to treat chronic HCV in adults in combination with other medicines. — Johnathan Rickman

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