EMA approves Upadacitinib for moderate to severe adult Rheumatoid Arthritis

European Medicines Agency has approved Upadacitinib a once-daily selective and reversible JAK inhibitor, for the treatment of adult patients with moderate to severely active rheumatoid arthritis who have responded inadequately to, or who are intolerant to one or more disease-modifying anti-rheumatic drugs (DMARDs). The Committee for Medicinal Products for Human Use (CHMP) of European Medicines Agency has adopted a positive opinion for the use of upadacitinib as monotherapy or in combination with methotrexate. Upadacitinib has been discovered and developed by AbbVie.

Upadacitinib is a selective and reversible JAK inhibitor under review with health authorities globally for the treatment of moderate to severely active rheumatoid arthritis and being studied in other immune-mediated inflammatory diseases.

"Rheumatoid arthritis is a chronic and debilitating disease affecting an estimated 23.7 million people worldwide. While significant treatment advances have been made over the past 20 years, many people living with the disease still do not achieve remission. The need for novel, innovative treatment options is critical," said Michael Severino, M.D., vice chairman and president, AbbVie. "We are pleased with this positive opinion from the CHMP recognizing upadacitinib's potential for patients with moderate to severely active rheumatoid arthritis. This regulatory milestone marks an important step towards our pursuit of delivering innovative therapies that address the unmet needs of patients living with rheumatoid arthritis."

The CHMP positive opinion is supported by data from the global Phase 3 SELECT rheumatoid arthritis program, evaluating more than 4,400 patients with moderate to severely active rheumatoid arthritis in five pivotal studies.^1-5 Across all five trials – SELECT-NEXT, SELECT-BEYOND, SELECT-MONOTHERAPY, SELECT-COMPARE and SELECT-EARLY – all primary and ranked secondary endpoints were met, including low disease activity based on Disease Activity Score 28 C-Reactive Protein (DAS28-CRP)≤3.2, clinical remission based on DAS28-CRP<2.6 and ACR20/50 (depending on study design); improved response was seen with upadacitinib both as monotherapy and in combination with conventional synthetic DMARDs compared to placebo, methotrexate or adalimumab (depending on study design).^1-5 Data from the SELECT program showed a consistent safety profile across the five studies.^1-5,7 The most frequently reported adverse reactions were infections.

The robust Phase 3 SELECT rheumatoid arthritis program evaluated more than 4,400 patients with moderate to severe active rheumatoid arthritis in five pivotal trials. The studies include assessments of efficacy, safety and tolerability across a broad spectrum of patients with rheumatoid arthritis, including those who were naïve to methotrexate and those who had an inadequate response or intolerance to one or more conventional synthetic or biologic DMARDs. Key measures of efficacy evaluated include ACR responses, DAS28-CRP and inhibition of radiographic progression.

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More information on the trials can be found at www.clinicaltrials.gov