FDA Accepts NDA of AbbVie’s Hepatitis C Oral RegimeBy
AbbVie reports that the US Food and Drug Administration (FDA) has accepted its new drug application (NDA) 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 virus (HCV) infection.
AbbVie said its regimen is the first all-oral, interferon-free therapy being evaluated by the FDA for patients in the United States with chronic GT4 HCV infection. The priority review designation shortens the regulatory review period for non-new chemical entity NDAs from the normal 10 months to six months. AbbVie’s regimen was also granted a Breakthrough Therapy designation by the FDA on June 30, 2014, a status given to investigational treatments for serious or life-threatening conditions with preliminary clinical evidence that may demonstrate substantial improvement on at least one clinically significant endpoint compared to available therapy.