Investigational Atopic Dermatitis Therapy Granted Breakthrough Therapy Status
The FDA has granted upadacitinib Breakthrough Therapy Designation for adult patients with moderate to severe atopic dermatitis (AD) who are candidates for systemic therapy.
Upadacitinib is an oral therapy that selectively inhibits JAK1 and is being studied as a once-daily treatment for atopic dermatitis and other immune-mediated diseases, such as psoriatic arthritis.
Breakthrough Therapy Designation status is granted to investigational treatments to expedite the development and review of medicines with preliminary clinical evidence that indicates it may substantially improve disease severity over existing therapies. Upadacitinib was granted Breakthrough Therapy Designation after positive results from the phase 2B trial conducted by AbbVie, which showed the therapy meet all primary endpoints.