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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