AbbVie earns FDA approval for Viekira Pak
Viekira Pak (ombitasvir, paritaprevir and ritonavir tablets; dasabuvir tablets) doesn’t include Ribavirin in genotype 1b chronic hepatitis C patients who have compensated cirrhosis.
The approval is based on the Turquoise-III study. It demonstrates a 100 percent SVR12 among chronic hepatitis C (virus) infected genotype 1b patients who have compensated cirrhosis.
"This provides a very useful option for people infected with genotype 1b infection and compensated cirrhosis," Jordan Feld, Turquoise-III lead investigator, research director and clinician scientist at the Toronto Center for Liver Disease, said. "The ability to cure these individuals with just 12 weeks of treatment and without the need for ribavirin is a great benefit. The outstanding 100 percent cure rate from the study confirms that this is likely to be a very effective strategy."
Earlier, the FDA granted priority review status to the Supplemental New Drug Application.
"We are constantly striving to advance clinical care for patients living with chronic hepatitis C," Michael Severino, chief scientific officer of AbbVie, said. "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."
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