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FDA grants priority review for oral, interferon-free treatment of HCV genotype 4
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The FDA has accepted AbbVie’s new drug application and granted priority review designation for an all-oral, interferon-free antiviral regimen to treat adult patients with hepatitis C virus genotype 4 infection, according to a press release.
The treatment consists of a fixed-dose combination of paritaprevir plus ritonavir (150 mg/100 mg) co-formulated with ombitasvir (25 mg) dosed once daily, and co-administered with weight-based ribavirin (1,000 mg or 1,200mg in divided doses) twice daily. It is the first oral, interferon-free genotype 4 HCV therapy being evaluated by the FDA.
The new drug filing was based in part on data from the PEARL-I phase 2b study, which reported 100% sustained virologic response at 12 weeks among noncirrhotic participants who were new to the therapy. Observed adverse events were acceptable and led to no discontinuations of treatment.
“We are pleased that the FDA has granted priority review for our all-oral, interferon-free treatment for patients with chronic [genotype 4] HCV infection,” Michael Severino, MD, AbbVie executive vice president and chief scientific officer of research and development, said in the release. “Submission of this NDA further underscores AbbVie’s commitment to developing therapies to treat a wide range of patients living with chronic HCV infection.”