EMA panel recommends approval of DAA regimen for HCV with cirrhosis
The European Committee for Medicinal Products for Human Use, or CHMP, granted a positive opinion for the recommendation of Viekirax plus Exviera, without ribavirin, for the treatment of chronic hepatitis C genotype 1b infection with compensated cirrhosis, according to a press release.
The Viekirax (omitasvir/paritaprevir/ritonavir, AbbVie) and Exviera (dasabuvir, AbbVie) combination was looked upon favorably based on data from the TURQUOISE-III phase 3 clinical trial. In the trial, 60 treatment-naive or treatment-experienced patients who failed previous therapy with pegylated interferon and ribavirin, were treated with the direct-acting antiviral regimen without ribavirin and 100% reached sustained virologic response 12 weeks post-treatment.
“This positive CHMP opinion brings us one step closer to delivering a ribavirin-free treatment option for GT1b patients with compensated cirrhosis that has demonstrated high cure rates with no treatment discontinuations in our clinical trial,” Michael Severino, MD, executive vice president of research and development and chief scientific officer at AbbVie, said in the release. “This milestone reinforces our continued commitment to provide additional treatment options for the HCV community.”
Ombitasvir/paritaprevir/ritonavir in combination with or without dasabuvir was approved by the European Union in January 2015 and is available for the treatment of chronic HCV genotype 1 and 4 infections in the United Kingdom, as well as in all 28 European Union member states.
Ombitasvir/paritaprevir/ritonavir in combination with dasabuvir, known as Viekira Pak (AbbVie) in the U.S., was approved by the FDA in December 2014 for treating patients with HCV genotype 1 infection and cirrhosis.
The FDA granted priority review to AbbVie’s supplemental new drug application for Viekira Pak without ribavirin for the treatment of HCV genotype 1b and compensated cirrhosis in January.
Disclosure: Severino is employed by AbbVie.