Enanta Pharma Announces NDA Submission To FDA For Hepatitis C Treatment

(RTTNews) - Enanta Pharmaceuticals Inc. (ENTA), Tuesday said AbbVie, Enanta's collaboration partner for ABT-450, has submitted a New Drug Application to the FDA seeking approval for an investigational, all-oral, interferon-free regimen for the treatment of adult patients with chronic genotype 1 hepatitis C virus infection.

The three direct-acting antiviral regimen consists of boosted protease inhibitor ABT-450/ritonavir, NS5A inhibitor ABT-267, and non-nucleoside polymerase inhibitor ABT-333. ABT-450 is the lead protease inhibitor developed through Enanta's collaboration with AbbVie.

"This submission marks a very significant step toward Enanta being part of the first wave of all-oral therapies that may be approved to treat patients with genotype 1 hepatitis C virus," stated Jay R. Luly, Ph.D., Enanta's President and Chief Executive Officer.