04:39 , Jan 17, 2015 |  BC Extra  |  Company News

EC approves AbbVie's HCV regimen

The European Commission approved Exviera dasabuvir and Viekirax , a two direct-acting-antiviral (2-DAA) combination of ombitasvir and paritaprevir plus the booster Norvir ritonavir from AbbVie Inc. (NYSE:ABBV) to treat chronic HCV infection. The EC approved...
02:24 , Nov 22, 2014 |  BC Extra  |  Company News

CHMP gives nod to AbbVie's HCV therapies

EMA's CHMP recommended approval of Exviera dasabuvir and Viekirax , which is a two direct-acting-antiviral (2-DAA) combination of ombitasvir and paritaprevir ( ABT-450 ) plus the booster Norvir ritonavir from AbbVie Inc. (NYSE:ABBV) to treat...
08:00 , Nov 17, 2014 |  BC Week In Review  |  Clinical News

ABT-450 plus ritonavir/ombitasvir: Phase II/III data

Data from 63 patients co-infected with HCV genotype 1 and HIV with or without compensated liver cirrhosis in part 1 of the 2-part, open-label, U.S. Phase II/III TURQUOISE-I trial showed that AbbVie's all-oral 3D regimen...
08:00 , Nov 17, 2014 |  BC Week In Review  |  Clinical News

ABT-450 plus ritonavir/ombitasvir: Phase II data

The open-label, international Phase II CORAL-I trial in 34 non-cirrhotic, liver transplant patients with recurrent chronic HCV genotype 1 infection showed that AbbVie's all-oral 3D regimen -- comprising co-administration with once-daily 150 mg ABT-450 plus...
07:00 , Jun 23, 2014 |  BC Week In Review  |  Clinical News

ABT-450 plus ritonavir/ombitasvir regulatory update

AbbVie and Enanta said EMA accepted for review a pair of MAAs for AbbVie’s all-oral HCV regimen comprising ABT-450 plus the company’s Norvir ritonavir, ABT-267 and ABT-333 with and without ribavirin to treat HCV genotype...
07:00 , Jun 16, 2014 |  BC Week In Review  |  Clinical News

ABT-450 plus ritonavir/ombitasvir regulatory update

AbbVie said FDA accepted and granted Priority Review to an NDA for the company's all-oral HCV regimen, which has breakthrough therapy designation from the agency. The NDA covers a regimen of ABT-450 plus Norvir ritonavir,...
07:00 , May 12, 2014 |  BC Week In Review  |  Clinical News

ABT-450 plus ritonavir/ombitasvir regulatory update

AbbVie submitted a pair of MAAs to EMA for its all-oral HCV regimen comprising ABT-450 plus the company's Norvir ritonavir, ABT-267 and ABT-333 with and without ribavirin to treat HCV genotype 1 infection. The company...
07:00 , May 5, 2014 |  BC Week In Review  |  Clinical News

ABT-450 plus ritonavir/ombitasvir: Additional Phase III data

Additional data from the open-label, international Phase III TURQUOISE-II (Study M13-099) trial in 380 patients with chronic HCV genotype 1 infection with compensated liver cirrhosis showed that AbbVie's all-oral 3D regimen - comprising co-administration with...
07:00 , Apr 28, 2014 |  BC Week In Review  |  Clinical News

ABT-450 plus ritonavir/ombitasvir regulatory update

AbbVie submitted an NDA to FDA for its all-oral regimen comprising ABT-450 plus the company's Norvir ritonavir, ABT-267 and ABT-333 with and without ribavirin to treat HCV genotype 1 infection. The regimen has breakthrough therapy...
08:00 , Feb 3, 2014 |  BC Week In Review  |  Clinical News

ABT-450 plus ritonavir/ABT-267/ABT-333: Phase III data

The open-label, international Phase III PEARL-II (Study M13-389) trial in 179 treatment-experienced patients with chronic HCV genotype 1b infection and no evidence of liver cirrhosis showed that AbbVie's all-oral 3D regimen - comprising co-administration with...