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news.The European Medicines Agency (EMA) has fully validated the Marketing Authorization Applications (MAAs) for AbbVie's Genotype 1 Chronic Hepatitis C regimen, marking the accelerated assessment of the therapy.
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The investigational, all-oral, interferon-free medicine is primarily indicated for the treatment of adult patients with chronic genotype 1 (GT1) hepatitis C virus (HCV) infection.
The three direct-acting antiviral investigational regimen for GT1 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 submission of the MAAs was based on the data from a large clinical program, conducted by AbbVie, including six phase 3 studies of more than 2,300 GT1 patients in over 25 countries.
The regimen, if approved, could be available for marketing in the European Union in the first quarter of 2015, according to AbbVie.
In December 2006, Enanta and Abbott signed an agreement to collaborate on the discovery, development and commercialization of HCV NS3 and NS3/4A protease inhibitors and HCV- protease-inhibitor-containing drug combinations.