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AbbVie Submits New Drug Application for All-Oral, Interferon-Free Regimen for Hepatitis C

Investigational treatment designated as ‘breakthrough therapy’

AbbVie has submitted a new drug application (NDA) to the FDA seeking approval for an investigational, all-oral, interferon (IFN)-free regimen for the treatment of adults with chronic genotype 1 (GT1) hepatitis C virus (HCV) infection.

The NDA was supported by data from the largest all-oral, IFN-free clinical program in GT1 patients conducted to date, with six phase III studies that included more than 2,300 patients.

In May 2013, AbbVie’s investigational direct-acting antiviral (DAA) regimen with and without ribavirin for HCV genotype 1 was designated a “breakthrough therapy” by the FDA. This designation is intended to help expedite the development of drugs for serious or life-threatening conditions and is partly based on preliminary clinical evidence demonstrating that a drug or regimen may offer substantial improvement on at least one clinically significant endpoint compared with available therapy.

The investigational regimen consists of 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 ribavirin (weight-based), dosed twice daily. According to AbbVie, the combination of three different mechanisms of action interrupts the HCV replication process, with the goal of optimizing sustained virologic response rates across different patient populations.

In the U.S., an estimated 3.2 million people have HCV infection, which is most prevalent among people born between 1945 and 1965.

Source: AbbVie; April 22, 2014.

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