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CHMP Recommends Approval of RINVOQ® (upadacitinib) for the Treatment of Atopic Dermatitis

Published: 2021-06-25 06:30:00 ET

- 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

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All statements made via social media sites sponsored or maintained by Enhanced Investments and its affiliates are for informational purposes only and do not constitute a comprehensive description of Enhanced Investments' investment advisory services.
Certain investments are not suitable for all investors. Before investing, consider your investment objectives and applicable fees. The rate of return on investments can vary widely over time, especially for long term investments. Investment losses are possible, including the potential loss of all amounts invested. Information provided by Enhanced Investments is for informational and general educational purposes only and is not investment or financial advice.