Image

The US Food and Drug Administration (FDA) has accepted and granted priority review to AbbVie’s new drug application for its interferon-free regimen to treat adult patients with chronic genotype 1 (GT1) hepatitis C virus (HCV) infection.

In April, AbbVie submitted the new drug application to the FDA for its investigational, all-oral, interferon-free therapy for the treatment of GT1 HCV.

Discover B2B Marketing That Performs

Combine business intelligence and editorial excellence to reach engaged professionals across 36 leading media platforms.

Find out more

The submission is supported by data from a large clinical programme, including six Phase III studies of more than 2,300 GT1 patients in at least 25 countries.

The multi-centre studies include PEARL-II, PEARL-III, PEARL-IV, TURQUOISE-II, SAPPHIRE-I and SAPPHIRE-II.

"The submission is supported by data from a large clinical programme, including six Phase III studies of more than 2,300 GT1 patients in at least 25 countries."

In May 2013, the FDA had granted a breakthrough therapy designation for the interferon-free regimen. AbbVie submitted marketing authorisation applications for regulatory approval in the EU in May 2014.

The three direct-acting antiviral investigational regimen consists of the fixed-dose combination of ABT-450/ritonavir (150/100mg) co-formulated with ombitasvir (ABT-267) 25mg, dosed once-daily, and dasabuvir (ABT-333) 250mg with or without ribavirin (weight-based), dosed twice-daily.

GlobalData Strategic Intelligence

US Tariffs are shifting - will you react or anticipate?

Don’t let policy changes catch you off guard. Stay proactive with real-time data and expert analysis.

By GlobalData

ABT-450 is Enanta Pharmaceuticals’ lead protease inhibitor developed through its collaboration with AbbVie. AbbVie is developing ABT-450 for use in combination with its other investigational medicines for the treatment of hepatitis C.

According to AbbVie, the combination of three different mechanisms of action interrupts the hepatitis C virus replication process with the goal of optimising sustained virologic response rates across different patient populations.


Image: 3D rendering of an hepatitis virus in digital background. Photo: courtesy of freedigitalphotos.net.

Pharmaceutical Technology Excellence Awards - The Benefits of Entering

Gain the recognition you deserve! The Pharmaceutical Technology Excellence Awards celebrate innovation, leadership, and impact. By entering, you showcase your achievements, elevate your industry profile, and position yourself among top leaders driving pharmaceutical advancements. Don’t miss your chance to stand out—submit your entry today!

Nominate Now