AbbVie applies for EU approval for new hepatitis C drug

AbbVie has announced the submission of marketing authorisation applications to the European Medicines Agency for a new treatment for hepatitis C.

The company is seeking approval for the investigational, all-oral, interferon-free regimen for the treatment of adult patients with chronic genotype 1 hepatitis C virus infection, based on positive data from six phase III trials.

Involving more than 2,300 patients in over 25 countries, the clinical programme was the largest conducted to date for an all-oral, interferon-free treatment in this patient group. The new regimen consists of ABT-450/ritonavir, ombitasvir and dasabuvir.

The European regulator also approved AbbVie's request for accelerated assessment for the new treatment method, a designation granted to new medicines of major public health interest.

Dr Scott Brun, vice-president for pharmaceutical development at AbbVie, said: "This regulatory milestone, on the heels of our submission of a new drug application in the US, represents an important step for our pipeline."

Earlier this month, the company reported data from the Pearl-III trial, which showed the benefits the therapy can offer to non-cirrhotic, adult patients with chronic genotype 1b hepatitis C virus infections who were new to treatment.