FDA Warnings And Restrictions On JAKs Curb Growth Potential Of Big Brands
Pfizer, AbbVie and Lilly will face new safety restrictions on Xeljanz, Rinvoq and Olumiant. Indication expansion remains uncertain, while first-line use appears out of the question.
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The leader in inflammatory bowel disease via Humira, AbbVie awaits a US FDA decision in June for Skyrizi in Crohn’s disease and plans to add a Crohn’s indication to Rinvoq’s ulcerative colitis approval.
The company is looking to refuel its immunology & inflammation portfolio as Xeljanz safety takes a toll and the franchise approaches loss of exclusivity.
While the atopic dermatitis market overall is crowded, the company sees a market opportunity for a drug that addresses both appearance and itching, as well as having favorable safety and ease of use.