AbbVie Korea said Wednesday that upadacitinib, its investigational therapy for atopic dermatitis, gained the “breakthrough therapy” status from the U.S. Food and Drug Administration.
The breakthrough therapy allows the FDA to give priority review to drug candidates when they offer significant treatment advantages over existing cures for severe or life-threatening diseases.
The recent designation is based on positive phase 2b results announced in September, the company said.
Upadacitinib (ABT-494) is AbbVie’s investigational, once-daily oral JAK-1 selective inhibitor used to treat adults with moderate to severe atopic dermatitis who are candidates for systemic therapy.
Atopic dermatitis is a chronic inflammatory skin disease characterized by skin erosion, oozing and crusting, redness, intense itching and dry skin. The American Academy of Dermatology estimates the condition to affect 28 million people in the U.S.
"Current treatment options for people living with atopic dermatitis are limited, and addressing these patient needs is important to us. We look forward to advancing upadacitinib into phase 3 studies for atopic dermatitis soon," said Michael Severino, AbbVie’s executive vice president of R&D and chief scientific officer.
The company currently has ongoing phase 3 trials for upadacitinib in rheumatoid arthritis, psoriatic arthritis, and Crohn's disease, and is investigating its use for ulcerative colitis, ankylosing spondylitis, and atopic dermatitis.
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