Thursday, May 22, 2014

Canada-AbbVie files NDS for all-oral, interferon-free therapy for the treatment of hepatitis C

AbbVie files New Drug Submission to Health Canada for its investigational, all-oral, interferon-free therapy for the treatment of hepatitis C

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 1. 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. 

"This is great news for Canadians living with hepatitis C," said Dr. Jordan Feld, of the Francis Family Liver Clinic at Toronto Western Hospital, part of the University Health Network. "We and our patients have been waiting for years to find an alternative to interferon. This new therapy leads to very high rates of cure for people with genotype 1 infection with just 12 weeks of treatment and no interferon. Access to these medications will allow us to treat and cure many more patients and prevent the devastating complications of this disease. It is truly a milestone moment." 

According to the Public Health Agency of Canada, an estimated 242,500 Canadians are living with hepatitis C, but approximately 21% of those individuals don't know they are infected and remain undiagnosed(2). 

About AbbVie's Investigational HCV Regimen
The AbbVie investigational regimen consists of the fixed-dose combination of ABT-450/ritonavir (150/100mg) co-formulated with ombitasvir (ABT-267) 25mg, dosed once daily, and dasabuvir (ABT-333) 250mg with or without RBV (weight-based), dosed twice daily. The combination of three different mechanisms of action interrupts the hepatitis C virus replication process with the goal of optimizing sustained virologic response rates across different patient populations. 

Additional information about AbbVie's Phase III studies can be found on www.clinicaltrials.gov .

Source-Market Watch

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