AbbVie's Upadacitinib US Application Review In Atopic Dermatitis Postponed

by Vandana Singh, Benzinga Editor

April 5, 2021 7:25 AM | 1 min read | Make a Comment

The FDA has extended the review period for AbbVie Inc's 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.