Posted by Michael Wonder on 08 Jan 2018
AbbVie's upadacitinib granted breakthrough therapy designation from the U.S. FDA for atopic dermatitis
8 January 2018 - Phase 3 clinical program for upadacitinib in atopic dermatitis, the most common type of eczema, is planned to begin in the first half of 2018.
AbbVie today announced the U.S. FDA granted breakthrough therapy designation for the investigational, once-daily oral JAK1-selective inhibitor upadacitinib (ABT-494) in adult patients with moderate to severe atopic dermatitis who are candidates for systemic therapy.
This breakthrough therapy designation is supported by positive Phase 2b results previously announced in September 2017,11 and marks 13 breakthrough therapy designations granted to AbbVie's investigational treatments since the company's inception in 2013. Upadacitinib is not approved by regulatory authorities and its safety and efficacy have not been established.
