April 22, 2014
AbbVie submitted a new drug application to the FDA for approval of an investigational regimen to treat adults with chronic genotype 1 hepatitis C virus infection, according to a press release from the biopharmaceutical company.
The direct-acting antiviral (DAA) treatment consists of a fixed-dose combination of ritonavir (ABT-450) at 150/100mg co-formulated with 25 mg of ombitasvir (ABT-267), dosed once daily, and 250mg of dasabuvir (ABT-333) with or without ribavirin, dosed twice daily, according to the release.
“This [New Drug Application] is a significant advancement for AbbVie’s HCV development program,” Scott Brun, MD, vice president of pharmaceutical development at AbbVie, said in the release. “Based on the robust data that have been generated in our international phase 3 HCV program, we believe our all-oral, interferon-free regimen holds the potential to be a promising new therapy for patients living with this chronic infection.”
Six phase 3 studies with more than 2,300 patients were conducted in over 25 countries, according to the release. The FDA assigned the DAA breakthrough therapy designation in May 2013, giving it priority review status as a potential major treatment advance.
AbbVie plans to submit an application for approval in the European Union in May, according to the release.