The European Commission (EC) has approved Abbvie’s JAK inhibitor Rinvoq (upadacitinib) for the treatment of moderate to severe atopic dermatitis in adults and adolescents 12 years and older who are candidates for systemic therapy.
The EC approval is supported by data from a large Phase III trial investigating Rinvoq monotherapy or with topical corticosteroids in 2,500 adults and adolescents. Rinvoq met all primary and secondary endpoints, demonstrating ‘rapid and significant’ improvement in skin clearance and itch reduction compared to placebo.
“As a dermatologist researching and treating atopic dermatitis for more than 25 years, I’ve seen first-hand the debilitating impact this disease can have on a person’s daily life,” said Alan Irvine, professor of dermatology, Trinity College Dublin, Ireland, and Rinvoq clinical study investigator.
“Clinicians need more tools to help them treat and manage this complex disease. The degree and early onset of skin clearance and itch relief in the Rinvoq Phase 3 clinical studies are very encouraging. The outcomes have the potential to advance treatment goals for patients with moderate to severe atopic dermatitis,” he added.
The decision marks the fourth EC-approved indication for Rinvoq, which is already authorised to treat rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis.
