November 21, 2014
By Mark Terry, BioSpace.com Breaking News Staff
Biotech giant AbbVie announced today that its hepatitis C virus treatment, VIEKIRAX + EXVIERA was granted positive opinions by the European Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA). A final decision, pending further review, is expected in the first quarter of 2015.
The CHMP opinions were based on a clinical development program made up of six pivotal Phase 3 studies involving more than 2,300 patients in over 25 countries. The studies are dubbed SAPPHIRE-I, SAPPHIRE-II, PEARL-II, PEARL-III, PEARL-IV and TURQUOISE-II. Data from a Phase 2 study called PEARL-1 involving GT4 patients without cirrhosis, was considered, as was data from TURQUOISE-I in GT1 HCV and HIV-1 co-infected patients. Additional data from the CORAL-I study in liver transplant recipients with recurrent GT1 HCV infection was also considered.
“The CHMP positive opinions mark an important milestone in our HCV development program and recognize the potential our treatment brings to people in Europe living with this chronic condition,” said Michael Severino, executive VP, research and development and AbbVie’s chief scientific officer in a statement. “Our treatment has been developed with the goal of achieving high cure rates in a broad range of genotype 1 patients with low rates of discontinuation and relapse.”
VIEKIRAX is a fixed-dose combination of paritaprevir, an NS3/4A protease inhibitor and ritonavir with ombitasvir, an NS5A inhibitor. EXVIERA is made up of 250mg of dasabuvir, a non-nucleoside NS5B polymerase inhibitor. The combination of VIEKIRAX + EXVIERA is being studied for the treatment of genotype 1 chronic hepatitis C virus infection, as well as in patients with compensated cirrhosis.
Both drugs were evaluated through EMA’s accelerated assessment plan. This has the goal of speeding up patient access to new medications in unmet areas of medical need. The CHMP opinion will be delivered to the European Commission, where a decision will be made for marketing authorization for the entire European Union. When and if that authorization is granted, each EU Member State will be involved in price and reimbursement decisions.
One of the compounds involved in the trials is paritaprevir, the generic name for ABT-450, an NS3/4A protease inhibitor. It was discovered via a collaboration between AbbVie, headquartered in North Chicago, Ill., and Watertown, Mass.-based Enanta Pharmaceuticals, Inc.
“These positive opinions are an important step in bringing to market a potential new cure for patients living with hepatitis C virus,” said Jay Luly, Enanta president and CEO in a statement. “We are thrilled that our protease inhibitor paritaprevir is part of such an important regimen and look forward to the European Commission’s final decision anticipated in the first quarter of 2015.”
