Regulators in the USA will make an accelerated assessment of AbbVie’s investigational all-oral interferon-free hepatitis C therapy.
Specifically, the US Food and Drug Administration has granted a priority review to the combination for the treatment of chronic genotype 1 HCV infection. The therapy consists of 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 fast-track means that the FDA will decide on approving the regimen within six months from the day the file was submitted, on April 21. AbbVie has already got breakthrough therapy designation for the combo, received from the agency in May 2013.
Last month, AbbVie submitted marketing authorisation applications for regulatory approval in the European Union, “supported by data from the largest all-oral, interferon-free clinical programme in GT1 patients conducted to date”, the company states. The file consists of six Phase III studies that include more than 2,300 patients.
Earlier this month, AbbVie noted that an 85 million euro expansion of its active pharmaceutical ingredient plant in Sligo, Ireland is complete. The move has created 175 new jobs in preparation for production of the HCV combo as it prepares to vie for a sizeable stake in the market which is currently dominated by Gilead Sciences’ Sovaldi (sofosbuvir).
