AbbVie snags priority review, breakthrough for HCV combo
This article was originally published in Scrip
The FDA has granted a priority review to AbbVie's new drug application for its all-oral, interferon-free, two direct-acting antiviral (2-DAA) treatment regimen consisting of the fixed-dose combination of ombitasvir, paritaprevir and ritonavir (OBV/PTV/r) with ribavirin (RBV) as a treatment for adults with chronic genotype 4 hepatitis C virus (HCV).
AbbVie's partner Enata Pharamaceuticals, whose lead protease inhibitor paritaprevir is part of the 2-DAA regimen, revealed the combo product also won a breakthrough therapy designation (BTD) from the FDA, which actually had bestowed the status on the medicine last June but the firms did not disclose it until 23 April. The BTD status is intended to expedited the regulatory process of drugs aimed at treating serious diseases.
Neither AbbVie nor Enanta disclosed the Prescription Drug User Fee Act action date for the OBV/PTV/r + RBV regimen.
Enanta's paritaprevir, an NS3/4A protease inhibitor also is one of the two DAA agents in AbbVie's recently approved HCV genotype 1 regimen Viekira Pak, which also consists of ombitasvir, an NS5A inhibitor; ritonavir, an protease inhibitor; and dasabuvir, a non-nucleoside NS5B palm polymerase inhibitor.
Under their collaboration, Enanta is eligible to receive annual tiered royalties ranging from the low double digits to up to 20% on 45% of AbbVie's worldwide net sales of any 2-DAA paritaprevir-containing regimen.