AbbVie says hepatitis C regimen gets nod for FDA priority review

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AbbVie says hepatitis C regimen gets nod for FDA priority review

(Reuters) - U.S. regulators have granted priority review for AbbVie Inc's experimental all-oral regimen for patients infected with the most common genotype of hepatitis C virus, the company said on Friday. The priority review means the Food and Drug Administration will likely decide within six months whether to approve the regimen, which was submitted to the agency on April 21. AbbVie said it had submitted in May marketing applications for regulatory approval in the European Union. AbbVie's regimen consists of protease inhibitor ABT-450, boosted by a widely used antiviral called ritonavir, combined with polymerase inhibitor dasabuvir, and NS5A inhibitor ombitasvir with or without the older antiviral drug ribavirin.

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