AbbVie has received a positive opinion for a shorter, eight-week treatment of VIEKIRAX (ombitasvir / paritaprevir / ritonavir tablets) + EXVIERA (dasabuvir tablets) as an option for previously untreated adult patients with genotype 1b (GT1b) chronic hepatitis C virus (HCV) and minimal-to-moderate fibrosis.
The positive opinion was given by European Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA).
Go deeper with GlobalData
Discover B2B Marketing That Performs
Combine business intelligence and editorial excellence to reach engaged professionals across 36 leading media platforms.
VIEKIRAX + EXVIERA is currently approved in the European Union for use as a 12-week treatment for GT1b chronic HCV-infected patients without cirrhosis or with compensated cirrhosis.
AbbVie research and development executive vice president Michael Severino said: "AbbVie continuously strives to expand the utility of our HCV treatments, including investigating a shorter path to virologic cure for people living with HCV.
"With this positive CHMP opinion, we will bring an eight-week treatment option for the many HCV patients with GT1b."
The GT1b subtype accounts for 47% of the nine million people infected with chronic HCV across Europe.
US Tariffs are shifting - will you react or anticipate?
Don’t let policy changes catch you off guard. Stay proactive with real-time data and expert analysis.
By GlobalDataThe positive opinion follows data from the Phase IIIb multicentre, open-label, single-arm Garnet study.
Results showed that following treatment with VIEKIRAX + EXVIERA for eight weeks, 98% of previously untreated GT1b chronic HCV infected patients achieved sustained virologic response at 12 weeks post-treatment.
The commonly reported adverse events were headache (21%), fatigue (17%), nasopharyngitis (8%), pruritus (8%), nausea (6%) and asthenia (5%).
