AbbVie’s VIEKIRA PAK® without Ribavirin Receives sNDA Approval for Chronic Hepatitis C
AbbVie’s VIEKIRA PAK® without ribavirin (RBV) received U. S. FDA approval for its supplemental New Drug Application (sNDA) for the treatment of genotype 1b chronic hepatitis C (CHC) with compensated cirrhosis.
It seems AbbVie is generating a strong portfolio for hepatitis C treatment. Few days back we told about the positive results shown by Abbvie’s investigational candidate– ABT-493 and ABT-530 with ribavirin in Phase II trials for genotype 1 CHC patients. Now, its star candidate, VIEKIRA PAK® without ribavirin for CHC treatment received sNDA approval by FDA. VIEKIRA PAK® is already a prescription medicine used with or without RBV for treatment of genotype 1 chronic HCV infection and those suffering from compensated cirrhosis.
A company can apply for sNDA for the product that has already an approved new drug application (NDA). By the approval of sNDA the company receives green signal for making any further changes in the product.
VIEKIRA PAK® which already had a Breakthrough Therapy designation, got FDA approval for the treatment of genotype 1 HCV infected patients in December 2014. It is a combination of three drugs- ombitasvir, paritaprevir and dasabuvir that synergistically inhibit the growth of HCV.
In the 12 weeks TURQUIOSE-III trial which was a muti-center, open-label, single-arm Phase 3b study, VIEKIRA PAK® showed 100% rate of SVR12 (sustained virologic response) for genotype 1 chronic HCV infected patients with compensated cirrhosis. The study results were included in the sNDA for securing FDA approval.
“We are constantly striving to advance clinical care for patients living with chronic hepatitis C,” said Michael Severino, M.D., executive vice president, research and development and chief scientific officer, AbbVie. “This approval is especially significant because patients with chronic HCV with compensated cirrhosis are among the tough to treat, and in our study VIEKIRA PAK demonstrated 100 percent cure rates in GT1b patients without the use of ribavirin.”
The three leading competitors- Gilead Sciences, Merck, and AbbVie have entered in a tight ball game in the field of HCV infection treatment. It will be interesting to see who will become the ultimate leader.
Featured image credit: Human liver and hepatic cell diagram. Digital illustration. © Thufir (Stock Photo ID: 125426636)