Priority review for AbbVie hepatitis combo

The Food and Drug Administration has accepted US drugmaker AbbVie’s (NYSE: ABBV) New Drug Application and granted priority review for the company's, all-oral, interferon-free, two direct-acting antiviral treatment of ombitasvir, paritaprevir, ritonavir (OBV/PTV/r), with ribavirin (RBV).

The NDA is for the treatment of adults with chronic genotype 4 (GT4) hepatitis C (HCV) infection. AbbVie's regimen is the first all-oral, interferon-free therapy being evaluated by the FDA for patients in the USA with chronic GT4 HCV infection.

The FDA granted priority review to AbbVie for the regimen based in part on data from the PEARL-I study, which was recently published online in The Lancet. The FDA grants priority review designation to investigational therapies that treat a serious condition and, if approved, would provide a significant improvement in safety or effectiveness. This designation shortens the regulatory review period for non-new chemical entity NDAs from the normal 10 months to six months.