AbbVie Submits NDA For Oral, Interferon-Free Hepatitis C DrugBy
AbbVie has submitted a new drug application to FDA seeking approval for the company’s investigational, all-oral, interferon-free regimen for the treatment of adult patients with chronic genotype 1 (GT1) hepatitis C virus (HCV) infection. The AbbVie investigational regimen consists of the fixed-dose combination of ABT-450/ritonavir (150/100 mg) co-formulated with ombitasvir (ABT-267) 25 mg, dosed once daily, and dasabuvir (ABT-333) 250 mg with or without ribavirin (weight-based), dosed twice daily. The combination of three different mechanisms of action interrupts the hepatitis C virus replication process with the goal of optimizing sustained virologic response rates across different patient populations.
ABT-450 was discovered during the ongoing collaboration between AbbVie and Enanta Pharmaceuticals for hepatitis C virus protease inhibitors and regimens that include protease inhibitors. ABT-450 is being developed by AbbVie for use in combination with AbbVie’s other investigational medicines for the treatment of hepatitis C.
In May of 2013, AbbVie’s investigational direct-acting antiviral regimen with and without ribavirin for HCV genotype 1 was designated as a Breakthrough Therapy by FDA. This designation is intended to help expedite the development of drugs for serious or life-threatening conditions and is based in part on preliminary clinical evidence demonstrating a drug or regimen may have substantial improvement on at least one clinically significant endpoint compared to available therapy.
AbbVie plans to submit applications for regulatory approval of its regimen in the European Union in early May.