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Friday, April 2, 2021

FDA extends review of Abbvie's sNDA for Rinvoq in atopic dermatitis

 

  • The FDA is extending the PDUFA data for Abbvie's (NYSE:ABBV) sNDA for the JAK inhibitor Rinvoq (upadacitinib) in moderate to severe atopic dermatitis by three months to Q3 2021.
  • AbbVie previously disclosed it received an information request from the FDA for an updated assessment of the benefit-risk profile for the drug in this indication and it responded.
  • Last month, Abbvie said the FDA was extending the PDUFA data for another Rinvoq sNDA in psoriatic arthritis to late Q2.

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