The FDA designates AbbVie's (ABBV -2.4%) JAK1 inhibitor upadacitinib a Breakthrough Therapy for treatment of atopic dermatitis. A Phase 3 study should launch by Q2.
Breakthrough Therapy status provides for more intensive guidance from the FDA on development, the involvement of more senior agency personnel and a rolling review of the marketing application.
Previously: FDA tags Novartis and Shire candidates Breakthrough Therapies (Jan. 4)
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