– Positive opinion based on three global Phase 3 pivotal studies evaluating the safety and efficacy of RINVOQ (15 mg or 30 mg, once daily) used with or without topical corticosteroids in adults and adolescents with moderate to severe atopic dermatitis[1],[2]
– If approved, this will be the fourth indication for RINVOQ in the European Union[3]
– The European Commission decision is anticipated in the third quarter of 2021
NORTH CHICAGO, Ill., June 25, 2021 /PRNewswire/ — AbbVie (NYSE: ABBV) today announced the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending the approval of RINVOQ® (upadacitinib), an oral, selective and reversible JAK inhibitor, for the expanded use in adults (15 mg or 30 mg, once daily) and adolescents 12 years and older (15 mg, once daily) with moderate to severe atopic dermatitis who are candidates for systemic therapy. RINVOQ is being studied in several immune-mediated inflammatory diseases.4-10
The CHMP positive opinion was supported by data from the global Phase 3 program evaluating more than 2,500 patients with moderate to severe atopic dermatitis across three global pivotal studies: Measure Up 1, Measure Up 2 and AD Up.1,2 Across the three studies, both doses of RINVOQ met all primary and secondary endpoints, demonstrating rapid and significant improvement in skin clearance and reduction in itch compared to placebo at week 16 and other time points (p<0.001) in patients with moderate to severe atopic dermatitis.1,2 The most commonly reported adverse events in patients treated with RINVOQ were acne, nasopharyngitis and upper respiratory tract infections.1,2
“This milestone is an important step forward in our journey to improve care for people living with atopic dermatitis,” said Michael Severino, M.D., vice chairman and president, AbbVie. “Despite available treatments, many people with moderate to severe forms of this disease continue to experience a relentless and burdensome cycle of skin and itch symptoms. We are encouraged that the CHMP has recognized RINVOQ’s potential as an additional treatment option for these patients.”
The CHMP positive opinion is a scientific recommendation for marketing authorization to the European Commission, which authorizes marketing approval in the European Union. The Marketing Authorization will be valid in all member states of the European Union, as well as Iceland, Liechtenstein, Norway and Northern Ireland. If approved, this will be the fourth indication for RINVOQ, and RINVOQ will be the first JAK inhibitor in the European Union to treat moderate to severe atopic dermatitis in both adults and adolescents 12 years and older.3
