- EU LABEL EXPANSION SUPPORTED BY HIGH CURE RATES SHOWN IN TURQUOISE-III STUDY, A DEDICATED PHASE 3B STUDY OF VIEKIRAX + EXVIERA WITHOUT RIBAVIRIN FOR 12 WEEKS
- 100 PERCENT SVR(12) (N=60/60) ACHIEVED IN GENOTYPE 1B PATIENTS WITH COMPENSATED CIRRHOSIS (CHILD-PUGH A); NO PATIENTS DISCONTINUED TREATMENT DUE TO ADVERSE EVENTS
Feb 26, 2016
NORTH CHICAGO, Ill., Feb. 26, 2016 /PRNewswire/ -- AbbVie (NYSE: ABBV), a global biopharmaceutical company, announced today that the European Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has granted a positive opinion for the use of VIEKIRAX® (ombitasvir/paritaprevir/ritonavir tablets) + EXVIERA® (dasabuvir tablets) without ribavirin (RBV) in chronic hepatitis C virus (HCV) infected genotype 1b (GT1b) patients with compensated cirrhosis (Child-Pugh A).
"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," saidMichael Severino, M.D., executive vice president, research and development and chief scientific officer, AbbVie. "This milestone reinforces our continued commitment to provide additional treatment options for the HCV community, and we look forward to the final decision by the European Commission."
Approximately 160 million people worldwide are infected with HCV.1 Genotype 1 is the most common type of HCV genotype, accounting for 60 percent of cases worldwide.2 In Europe, the most prevalent genotype is 1b, accounting for 47 percent of the nine million people infected with chronic HCV.3,4
The CHMP opinion of the Type-II variation application for VIEKIRAX + EXVIERA is supported by data from the Phase 3b TURQUOISE-III study, which is part of AbbVie's larger clinical program investigating efficacy and safety in a broad range of GT1 patients. TURQUOISE-III is a dedicated Phase 3 study of VIEKIRAX + EXVIERA without RBV for 12 weeks in GT1b patients with compensated cirrhosis. Results from the TURQUOISE-III study showed 100 percent (n=60/60) of GT1b chronic HCV infected patients with compensated cirrhosis (Child-Pugh A) achieved sustained virologic response at 12 weeks post-treatment (SVR12) with VIEKIRAX + EXVIERA without RBV for 12 weeks.5 No patients discontinued treatment due to adverse events. The most commonly reported adverse events (>10 percent) were fatigue (22 percent), diarrhea (20 percent) and headache (18 percent).5
On January 7, AbbVie announced that its supplemental New Drug Application (sNDA) for VIEKIRA PAK® was accepted and granted priority review by the U.S. Food and Drug Administration (FDA).
About VIEKIRAX® + EXVIERA®
VIEKIRAX + EXVIERA is approved in the European Union for the treatment of genotype 1 (GT1) chronic hepatitis C virus (HCV) infection, including patients with compensated cirrhosis. VIEKIRAX is approved in the European Union for the treatment of genotype 4 (GT4) chronic HCV infection.
VIEKIRAX tablets consist of the fixed-dose combination of paritaprevir 150mg (NS3/4A protease inhibitor) and ritonavir 100mg with ombitasvir 25mg (NS5A inhibitor), dosed once daily. EXVIERA tablets consist of dasabuvir 250mg (non-nucleoside NS5B polymerase inhibitor) dosed twice daily. VIEKIRAX + EXVIERA are taken with or without ribavirin (RBV), dosed twice daily based on patient type. VIEKIRAX + EXVIERA is taken for 12 weeks with or without RBV, except in genotype 1a and GT4 patients with compensated cirrhosis, who should take it for 24 weeks with RBV.
Paritaprevir was discovered during the ongoing collaboration between AbbVie and Enanta Pharmaceuticals (NASDAQ: ENTA) for hepatitis C protease inhibitors and regimens that include protease inhibitors. Paritaprevir has been developed by AbbVie for use in combination with AbbVie's other investigational medicines for the treatment of chronic hepatitis C.
Additional information about AbbVie's hepatitis C development program can be found on www.clinicaltrials.gov.
NORTH CHICAGO, Ill., Feb. 26, 2016 /PRNewswire/ -- AbbVie (NYSE: ABBV), a global biopharmaceutical company, announced today that the European Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has granted a positive opinion for the use of VIEKIRAX® (ombitasvir/paritaprevir/ritonavir tablets) + EXVIERA® (dasabuvir tablets) without ribavirin (RBV) in chronic hepatitis C virus (HCV) infected genotype 1b (GT1b) patients with compensated cirrhosis (Child-Pugh A).
"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," saidMichael Severino, M.D., executive vice president, research and development and chief scientific officer, AbbVie. "This milestone reinforces our continued commitment to provide additional treatment options for the HCV community, and we look forward to the final decision by the European Commission."
Approximately 160 million people worldwide are infected with HCV.1 Genotype 1 is the most common type of HCV genotype, accounting for 60 percent of cases worldwide.2 In Europe, the most prevalent genotype is 1b, accounting for 47 percent of the nine million people infected with chronic HCV.3,4
The CHMP opinion of the Type-II variation application for VIEKIRAX + EXVIERA is supported by data from the Phase 3b TURQUOISE-III study, which is part of AbbVie's larger clinical program investigating efficacy and safety in a broad range of GT1 patients. TURQUOISE-III is a dedicated Phase 3 study of VIEKIRAX + EXVIERA without RBV for 12 weeks in GT1b patients with compensated cirrhosis. Results from the TURQUOISE-III study showed 100 percent (n=60/60) of GT1b chronic HCV infected patients with compensated cirrhosis (Child-Pugh A) achieved sustained virologic response at 12 weeks post-treatment (SVR12) with VIEKIRAX + EXVIERA without RBV for 12 weeks.5 No patients discontinued treatment due to adverse events. The most commonly reported adverse events (>10 percent) were fatigue (22 percent), diarrhea (20 percent) and headache (18 percent).5
On January 7, AbbVie announced that its supplemental New Drug Application (sNDA) for VIEKIRA PAK® was accepted and granted priority review by the U.S. Food and Drug Administration (FDA).
About VIEKIRAX® + EXVIERA®
VIEKIRAX + EXVIERA is approved in the European Union for the treatment of genotype 1 (GT1) chronic hepatitis C virus (HCV) infection, including patients with compensated cirrhosis. VIEKIRAX is approved in the European Union for the treatment of genotype 4 (GT4) chronic HCV infection.
VIEKIRAX tablets consist of the fixed-dose combination of paritaprevir 150mg (NS3/4A protease inhibitor) and ritonavir 100mg with ombitasvir 25mg (NS5A inhibitor), dosed once daily. EXVIERA tablets consist of dasabuvir 250mg (non-nucleoside NS5B polymerase inhibitor) dosed twice daily. VIEKIRAX + EXVIERA are taken with or without ribavirin (RBV), dosed twice daily based on patient type. VIEKIRAX + EXVIERA is taken for 12 weeks with or without RBV, except in genotype 1a and GT4 patients with compensated cirrhosis, who should take it for 24 weeks with RBV.
Paritaprevir was discovered during the ongoing collaboration between AbbVie and Enanta Pharmaceuticals (NASDAQ: ENTA) for hepatitis C protease inhibitors and regimens that include protease inhibitors. Paritaprevir has been developed by AbbVie for use in combination with AbbVie's other investigational medicines for the treatment of chronic hepatitis C.
Additional information about AbbVie's hepatitis C development program can be found on www.clinicaltrials.gov.
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