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Enanta Pharmaceuticals Reports U.S. FDA Awards Priority Review to AbbVie

June 18, 2014

Enanta Pharmaceuticals noted that the New Drug Application (NDA) for AbbVie's investigational, all-oral, interferon-free regimen for the treatment of adult patients with chronic genotype 1 (GT1) hepatitis C virus (HCV) infection has been accepted by the U.S. Food and Drug Administration (FDA) and has been granted priority review.

According to a release from the Company, 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's lead protease inhibitor developed through Enanta's collaboration with AbbVie.

The NDA was submitted on April 21, and is supported by data from a large clinical program being conducted by AbbVie, including six phase 3 studies of more than 2,300 GT1 patients in over 25 countries. The regimen was granted a Breakthrough Therapy designation by the FDA in May 2013, a status given to investigational treatments for serious or life-threatening conditions with preliminary clinical evidence demonstrating substantial improvement on at least one clinically significant endpoint compared to available therapy.

In May 2014, AbbVie submitted marketing authorization applications (MAAs) for regulatory approval in the European Union.

In addition, Enanta confirmed that in the quarter ending June 30, it has now received from AbbVie milestone payments totaling $40 million related to these regulatory filings.

Enanta Pharmaceuticals is a research and development-focused biotechnology company.

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Source: Professional Services Close - Up

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