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June 15, 2014

FDA grants priority review for Abbvie’s hepatitis C therapy new drug application

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.

By Mekala ShivaramPrasad

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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.

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.

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.

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