AbbVie files for EU marketing approval for its all-oral, interferon-free hepatitis C therapy

US drugmaker AbbVie (NYSE: ABBV) has submitted marketing authorization applications (MAAs) to the European Medicines Agency for approval of its investigational, all-oral, interferon-free regimen for the treatment of adult patients with chronic genotype 1 (GT1) hepatitis C virus (HCV) infection.

The MAAs are supported by data from the largest all-oral, interferon-free clinical program in GT1 patients conducted to date, which consists of six Phase III studies that include more than 2,300 patients in over 25 countries.

"These regulatory submissions bring us closer to offering adult genotype 1 chronic hepatitis C patients an all-oral, interferon-free regimen which has the potential to provide a promising advancement for the hepatitis C community in the European Union," said Scott Brun, vice president, pharmaceutical development, at AbbVie. "This regulatory milestone, on the heels of our submission of a New Drug Application in the USA, represents an important step for our pipeline," he added.