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Wednesday, 03/17/2021 9:25:41 AM

Wednesday, March 17, 2021 9:25:41 AM

Post# of 749
Rinvoq PDUFA date for psoriatic arthritis extended 3 months to “late 2Q21”:

https://finance.yahoo.com/news/abbvie-announces-extension-review-supplemental-124500090.html

AbbVie recently received an information request from the FDA for an updated assessment of the benefit-risk profile for upadacitinib in psoriatic arthritis. AbbVie responded to the request and the FDA will require additional time for a full review of the submission.

Separately, AbbVie received a similar request from the FDA related to the sNDA for upadacitinib in atopic dermatitis, which is being prepared and will be submitted to the FDA shortly.


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