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AbbVie Receives CHMP Positive Opinion for Upadacitinib (RINVOQ™) for the Treatment of Adults with Moderate to Severe Active Rheumatoid Arthritis
- In Phase 3 trials, upadacitinib improved signs and symptoms of rheumatoid arthritis, inhibited radiographic progression and improved physical function, both as a monotherapy and in combination with conventional synthetic DMARDs[1-5]
- Upadacitinib (under the trade name RINVOQ™) is a selective and reversible JAK inhibitor discovered and developed by AbbVie
NORTH CHICAGO, Ill., Oct. 18, 2019 /PRNewswire/ -- AbbVie (ABBV), a research-based global biopharmaceutical company, today announced that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion for RINVOQ™ (upadacitinib), a once-daily selective and reversible JAK inhibitor, for the treatment of adult patients with moderate to severe active rheumatoid arthritis who have responded inadequately to, or who are intolerant to one or more disease-modifying anti-rheumatic drugs (DMARDs). The positive opinion is for use of upadacitinib as monotherapy or in combination with methotrexate.
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 severe 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.1-5
"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 severe 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 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 and Norway. The Commission decision is anticipated within 67 days following the CHMP opinion.seekingalpha.com/pr/17667160-abbvie-r...