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.
Go deeper with GlobalData
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.
How well do you really know your competitors?
Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.
Thank you!
Your download email will arrive shortly
Not ready to buy yet? Download a free sample
We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form
By GlobalData“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.
