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AbbVie's Upadacitinib US Application Review In Atopic Dermatitis Postponed

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AbbVie's Upadacitinib US Application Review In Atopic Dermatitis Postponed
  • The FDA has extended the review period for AbbVie Inc's (NYSE: ABBV) supplemental marketing application seeking upadacitinib approval to treat adults and adolescents with moderate to severe atopic dermatitis.
  • The action date has been extended three months to early Q3 2021.
  • As previously disclosed, AbbVie received an information request from the FDA for an updated assessment of the benefit-risk profile for upadacitinib in atopic dermatitis.
  • AbbVie responded to the request.
  • Earlier in March, the FDA extended the review period for upadacitinib application for active psoriatic arthritis.
  • Price Action: ABBV shares are trading 0.09% higher at $108.55 in the premarket on the last check Monday.
 

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Posted-In: atopic dermatitisBiotech News Health Care FDA General

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