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 being developed through Enanta’s collaboration with AbbVie.
The MAAs are supported by AbbVie’s data from the all-oral, interferon-free clinical program carried out in GT1 patients, which includes data from six Phase III studies involving over 2,300 patients in over 25 countries.
AbbVie vice president of Pharmaceutical Development Scott Brun said these regulatory submissions brings 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 European Union.
"This regulatory milestone, on the heels of our submission of a New Drug Application in the U.S., represents an important step for our pipeline," Brun said.
EMA has granted AbbVie’s request for accelerated assessment for ABT-450/ritonavir, ombitasvir (ABT-267), and dasabuvir (ABT-333).