BRIEF—Breakthrough status for upadacitinib in atopic dermatitis

The US Food and Drug Administration has granted Breakthrough Therapy Designation for the investigational, once-daily oral JAK1-selective inhibitor upadacitinib in adults with moderate to severe atopic dermatitis (AD) who are candidates for systemic therapy.

This candidate from AbbVie is backed by positive Phase IIb results in AD and the US drugmaker plans to take it into Phase III studies soon.

Phase III trials of upadacitinib in rheumatoid arthritis, psoriatic arthritis and Crohn's disease are already underway and it is also being investigated to treat ulcerative colitis and ankylosing spondylitis.