Boehringer Ingelheim to receive accelerated assessment for hepatitis drug

Boehringer Ingelheim has announced that its new hepatitis C therapy faldaprevir is to receive an accelerated European regulatory approval process.

The potent second-generation oral protease inhibitor has been fully validated and granted accelerated assessment status by the European Medicines Agency (EMA), based on the positive performance it has shown in clinical trials.

Faldaprevir has been submitted for approval in combination with pegylated interferon and ribavirin for the treatment of a broad range of patients with genotype-1 hepatitis C, including those with HIV co-infection or advanced liver disease.

It has been shown to provide strong efficacy and a robust safety profile, as well as the convenience of once-daily dosing and no food restrictions.

Professor Klaus Dugi, corporate senior vice-president for medicine at Boehringer Ingelheim, said: "The acceptance for accelerated assessment by the EMA supports our position that if approved, faldaprevir will provide an important alternative to currently available hepatitis C treatments."

The company also filed for European regulatory approval of tiotropium Respimat as a treatment for adult patients with asthma earlier this month.