US FDA green lights two JAK inhibitors for atopic dermatitis

15 January 2022

Having cast a shadow over the safety of the JAK inhibitor class of drugs in September last year, and delayed clearance of new drugs, on Friday the US Food and Drug Administration approved not one, but two new medicines in the category: Pfizer’s (NYSE: PFE) Cibinqo (abrocitinib) and AbbVie’s (NYSE: ABBV) Rinvoq (upadacitinib).

Also, last month the regulator added its strictest warning labels to Pfizer and AbbVie’s drugs, as well as Eli Lilly’s (NYSE: LLY) Olumiant (baricitinib), which is still under FDA review for atopic dermatitis. The new approvals carry strong label warnings.

Cibinqo is approved for the treatment of adults living with refractory, moderate-to-severe atopic dermatitis (AD) whose disease is not adequately controlled with other systemic drug products, including biologics, or when use of those therapies is inadvisable.

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