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.

Go deeper with GlobalData

Go deeper with GlobalData

The gold standard of business intelligence.

Find out more

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 - Nominations Closed

Nominations are now closed for the Pharmaceutical Technology Excellence Awards. A big thanks to all the organisations that entered – your response has been outstanding, showcasing exceptional innovation, leadership, and impact.

Excellence in Action
Imagene’s Oncology Intelligence (OI) Suite has won the Innovation Award for Precision Oncology, for transforming how pharma designs and runs oncology trials. From AI-driven biomarker discovery to smarter patient stratification, see how Imagene is cutting time, cost and risk in cancer drug development.

Discover the Impact