US-based biopharmaceutical firm AbbVie has submitted marketing authorisation applications (MAAs) to the European Medicines Agency (EMA) seeking approval for its investigational, all-oral, interferon-free regimen to treat adults with chronic genotype 1 (GT1) hepatitis C virus (HCV) infection.
The investigational regimen includes 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 discovered under an ongoing collaboration between AbbVie and Enanta Pharmaceuticals for hepatitis C virus protease inhibitors and regimens that include protease inhibitors.
AbbVie is developing ABT-450 for use in combination with its other investigational medicines to treat hepatitis C.
The submission is based on AbbVie’s data from the all-oral, interferon-free clinical programme carried out in GT1 patients, which includes data from six Phase III trials involving over 2,300 patients in more than 25 countries.
AbbVie vice-president of Pharmaceutical Development Scott Brun said these regulatory submissions bring the company closer to offering adult genotype 1 chronic hepatitis C patients an all-oral, interferon-free regimen, which has the potential to provide a promising advancement for the hepatitis C community in the EU.
“This regulatory milestone, on the heels of our submission of a new drug application in the US, represents an important step for our pipeline,” Brun added.
The EMA has also granted AbbVie’s request for accelerated assessment for ABT-450/ritonavir, ombitasvir (ABT-267), and dasabuvir (ABT-333) and if approved they will be available for marketing in the EU in the first quarter of 2015.
Every year, an estimated 160 million people are chronically infected with hepatitis C worldwide and an estimated 3.5 million people are newly infected each year.
In Europe, approximately 17.5 million people have chronic hepatitis C, with GT1 as the predominant genotype.
Image: Electron micrograph of hepatitis C virus. Photo: courtesy of TimVickers.
