AbbVie announced the U.S. Food and Drug Administration (FDA) has approved RINVOQ® (upadacitinib) for the treatment of moderate to severe atopic dermatitis in adults and children 12 years of age and older whose disease did not respond to previous treatment and is not well controlled with other pills or injections, including biologic medicines, or when use of other pills or injections is not recommended. RINVOQ 15 mg once daily can be initiated in adults and children 12 years of age and older weighing at least 40 kg. In these children and adults less than 65 years of age who do not achieve an adequate response, the dose may be increased to 30 mg once daily.
Thomas Hudson, M.D., senior vice president, research and development, chief scientific officer, AbbVie:
Early in my career as an allergist, I saw how relentless the itch and rash could be for my patients with moderate to severe atopic dermatitis yet had limited options to offer those whose disease could not be adequately controlled with systemic therapy. This additional approval for RINVOQ provides a once-daily oral option that can significantly improve the debilitating itch and skin symptoms of atopic dermatitis. It’s also a proud moment for AbbVie as we continue our efforts to improve care in this disease state and other chronic, immune-mediated conditions.
The FDA approval is supported by efficacy and safety data from one of the largest registrational Phase 3 programs for atopic dermatitis with more than 2,500 patients evaluated across three studies. Approximately 52 percent of the patients had prior exposure to systemic atopic dermatitis treatment. These studies evaluated the efficacy and safety of RINVOQ monotherapy (Measure Up 1 and 2) and with topical corticosteroids (AD Up), compared to placebo, in adults and children 12 years of age and older with moderate to severe atopic dermatitis.
Emma Guttman-Yassky, M.D., Ph.D., Waldman Professor and System Chair of Dermatology at the Icahn School of Medicine at Mount Sinai in New York City:
Despite available therapies, many people with moderate to severe atopic dermatitis are caught in an endless cycle of itching and scratching. In clinical trials, upadacitinib showed a robust response across skin and itch symptoms that may help evolve treatment goals for those who have not achieved adequate control of their disease. And as an oral pill with two dose strengths, upadacitinib is a welcome addition to the toolbox of clinicians who are striving to make a significant difference for their patients with moderate to severe atopic dermatitis.