24 Apriul 2015 - Enanta Pharmaceuticals, Inc., a research and development-focused biotechnology company dedicated to creating small molecule drugs for viral infections and liver diseases, announced today that AbbVie has stated that the U.S. Food and Drug Administration (FDA) has accepted AbbVie’s New Drug Application (NDA) and granted priority review for its all-oral, interferon-free, two direct-acting antiviral (2-DAA) treatment regimen consisting of the fixed-dose combination of ombitasvir, paritaprevir, ritonavir (OBV/PTV/r), with ribavirin (RBV) for the treatment of adult patients with chronic genotype 4 (GT4) hepatitis C virus (HCV) infection.

The FDA grants priority review designation to investigational therapies that treat a serious condition and, if approved, would provide a significant improvement in safety or effectiveness. AbbVie’s regimen was also granted a Breakthrough Therapy designation by the FDA on June 30, 2014, a status given to investigational treatments for serious or life-threatening conditions with preliminary clinical evidence that may demonstrate substantial improvement on at least one clinically significant endpoint compared to available therapy.1

Paritaprevir is Enanta’s lead protease inhibitor identified within the ongoing Enanta-AbbVie collaboration and is one of the two DAAs in AbbVie’s treatment regimen included in the NDA for the treatment of GT4 chronic hepatitis C patients. AbbVie is responsible for all development and commercialization activities for regimens that contain paritaprevir. Paritaprevir is included in AbbVie’s GT1 HCV treatment regimens approved in the U.S. in late 2014 and in the E.U. in early 2015. In addition, Enanta will be eligible to receive annually tiered royalties ranging from the low double digits up to twenty percent, on 45% of AbbVie’s worldwide net sales of any 2-DAA paritaprevir-containing regimen.

For more details, go to: http://ir.enanta.com/phoenix.zhtml?c=147990&p=irol-newsArticle&ID=2039274