AbbVie filed a New Drug Submission (NDS) to Health Canada seeking approval for the company's investigational, all-oral, interferon-free regimen for the treatment of adult patients with genotype 1 (GT1) chronic hepatitis C virus (HCV) infection, including patients with cirrhosis. The NDS is supported by data from the largest all-oral, interferon-free clinical program in GT1 patients conducted to date,(1) with six Phase III studies that included more than 2,300 patients in over 25 countries.

"This latest regulatory submission is yet another significant achievement for AbbVie's HCV development program," said Felipe Pastrana, General Manager, AbbVie Canada. "Our all-oral, interferon-free regimen offers adults living with genotype 1 chronic hepatitis C a promising solution to a worldwide problem."

On May 1(st), 2014, Health Canada approved AbbVie's request for Priority Evaluation for its investigational direct-acting antiviral (DAA) regimen with and without ribavirin for HCV genotype. An informal Bureau Adjudicating Committee reviewed the request and concluded that the regimen fulfilled the criteria for Priority Evaluation. This designation is intended to help expedite the development of drugs for serious or life-threatening conditions and is based in part on preliminary clinical evidence demonstrating a drug or regimen may have substantial improvement on at least one clinically significant endpoint compared to available therapy.

For more details, go to: http://www.marketwatch.com/story/abbvie-files-new-drug-submission-to-health-canada-for-its-investigational-all-oral-interferon-free-therapy-for-the-treatment-of-hepatitis-c-2014-05-22