AbbVie has filed its keenly-watched hepatitis C combination with regulators in Europe.
The company is seeking approval from the European Medicines Agency for its all-oral, interferon-free regimen for the treatment of chronic genotype 1 HCV infection. The therapy combines three antivirals - ABT-450/ritonavir (150/100mg) co-formulated with ombitasvir, (ABT-267) 25mg, dosed once daily, and dasabuvir (ABT-333) 250mg, dosed twice daily.
The submissions are supported by data from the largest all-oral, interferon-free clinical programme in GT1 patients conducted to date, AbbVie notes. The file consists of six Phase III studies that include more than 2,300 patients in over 25 countries.
The EMA has granted accelerated assessment for the combo, granted to new medicines of major public health interest. This should shorten review time by approximately two months and if approved, the therapy could be available for marketing in the EU in the first quarter of 2015; it was filed in the USA a fortnight ago.
The submission triggers a $20 million Payment to Enanta Pharmaceuticals, AbbVie's partner for ABT-450, a protease inhibitor. Ombitasvir is an NS5A inhibitor and dasabuvir is a non-nucleoside polymerase inhibitor.