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AbbVie HCV regimen gets priority review

  • The FDA grants AbbVie's (ABBV +0.9%) three-drug HCV regimen priority review. The company submitted its NDA on April 21, 2014.
  • The antiviral interferon-free fixed-dose combination consists of ABT-450 (ritonavir) co-formulated with ABT-267 (ombitasvir) and ABT-333 (dasabuvir) with or without ribavarin. ABT-450 was co-developed with Enanta Pharmaceuticals (ENTA).
  • In May 2014 ABBV submitted its marketing authorization applications to the EMA for regulatory approval in the EU.
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