AbbVie Submits New Drug Application for Hepatitis C Regimen

Yet another New Drug Application (NDA) for the treatment of hepatitis C has been filed with US regulators, this time by AbbVie Inc. for its all-oral, interferon-free therapy for patients with chronic genotype 1 hepatitis C virus infection.

In announcing the filing of its latest NDA, AbbVie revealed that the FDA has given the investigational regimen a breakthrough therapy status for treatment of chronic hepatitis C virus (HCV). When granted breakthrough status, drug makers are given early access to the FDA to expedite the development of a drug for a serious or life threatening condition when early trial evidence demonstrates promising improvement over available therapy.

The application includes data from six phase 3 clinical studies that involved 2,300 patients in more than 25 countries, according to a news release from AbbVie. The company says it will submit an application next month to seek European regulatory approval for the regimen.

The clinical program is for an all-oral, interferon-free drug regimen for adults with chronic genotype 1 HCV infection. Traditional treatment of the virus involves injections with interferon that often cause serious side effects that discourage some patients from seeking treatment.

“This NDA submission is a significant advancement for AbbVie's HCV development program,” said Scott Brun, MD, AbbVie’s vice president of pharmaceutical development. “Based on the robust data that have been generated in our international phase III 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.”

The announcement describes the AbbVie investigational regimen as a 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 RBV (weight-based), dosed twice daily. The goal of the combination therapy is to optimize sustained virologic response rates across different patient populations.

Hepatitis C is a blood-borne virus that can lead to cirrhosis and cancer of the liver but symptoms often don’t appear for years until the virus has severely damaged the liver. Health officials estimated that about 3 million people in the US and up to 150 million worldwide have chronic infection of the virus, which is spread from one person to another mostly by sharing needles or other drug injection materials.

In the past three years, the FDA approved four drugs to treat HCV. The most recent approvals came in 2013 with Solvaldi (sofosbuvir) and Olysio (simeprevir). The FDA gave the nod to Victrelis (boceprevir) and Incivek (telaprevir) in 2011.

The pace of NDA submissions has picked up in 2014 as more drug companies join the race to win FDA approval for newer, faster, oral HCV drugs with fewer serious side effects. Earlier this month Bristol-Meyers Squibb submitted two NDAs to treat HCV with daclatasvir and asunaprevir and Gilead Sciences announced FDA priority review status for its NDA, submitted in February, for a once daily combination treatment for patients with genotype 1 HCV.