AbbVie Receives CHMP Positive Opinion for Upadacitinib (RINVOQ™) for the Treatment of Adults with Moderate to Severe Active Rheumatoid Arthritis

- CHMP positive opinion, supported by data from the pivotal Phase 3 SELECT rheumatoid arthritis program evaluating more than 4,400 patients, will now be referred to the European Commission for final approval[1-5]

- 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[6]

News provided by

AbbVie

Oct 18, 2019, 07:30 ET

NORTH CHICAGO, Ill., Oct. 18, 2019 /PRNewswire/ -- AbbVie (NYSE: 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.^1-5,7The 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.

About the SELECT Study Program^1-5

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. More information on these trials can be found at www.clinicaltrials.gov (NCT02706847, NCT03086343, NCT02629159, NCT02706873, NCT02706951).

About RINVOQ (upadacitinib)

Discovered and developed by AbbVie, RINVOQ is a selective and reversible JAK inhibitor under review with health authorities globally for the treatment of moderate to severe active rheumatoid arthritis and being studied in other immune-mediated inflammatory diseases.^1-16 Phase 3 trials of RINVOQ in psoriatic arthritis, Crohn's disease, atopic dermatitis, ulcerative colitis and giant cell arteritis are ongoing and it is also being investigated to treat ankylosing spondylitis.^10-16

About AbbVie

AbbVie is a global, research and development-based biopharmaceutical company committed to developing innovative advanced therapies for some of the world's most complex and critical conditions. The company's mission is to use its expertise, dedicated people and unique approach to innovation to markedly improve treatments across four primary therapeutic areas: immunology, oncology, virology and neuroscience. In more than 75 countries, AbbVie employees are working every day to advance health solutions for people around the world. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, LinkedIn or Instagram.

Forward-Looking Statements

Some statements in this news release are, or may be considered, forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995. The words "believe," "expect," "anticipate," "project" and similar expressions, among others, generally identify forward-looking statements. AbbVie cautions that these forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those indicated in the forward-looking statements. Such risks and uncertainties include, but are not limited to, competition from other products, challenges to intellectual property, difficulties inherent in the research and development process, adverse litigation or government action, and changes to laws and regulations applicable to our industry. Additional information about the economic, competitive, governmental, technological and other factors that may affect AbbVie's operations is set forth in Item 1A, "Risk Factors," of AbbVie's 2018 Annual Report on Form 10-K, which has been filed with the Securities and Exchange Commission. AbbVie undertakes no obligation to release publicly any revisions to forward-looking statements as a result of subsequent events or developments, except as required by law.

References:

Burmester GR, et al. Safety and efficacy of upadacitinib in patients with rheumatoid arthritis and inadequate response to conventional synthetic disease-modifying anti-rheumatic drugs (SELECT-NEXT): a randomised, double-blind, placebo-controlled phase 3 trial. Lancet. 2018 Jun 23;391(10139):2503-2512. doi: 10.1016/S0140-6736(18)31115-2. Epub 2018 Jun 18.
Genovese MC, et al. Safety and efficacy of upadacitinib in patients with active rheumatoid arthritis refractory to biologic disease-modifying anti-rheumatic drugs (SELECT-BEYOND): a double-blind, randomised controlled phase 3 trial. Lancet. 2018 Jun 23;391(10139):2513-2524. doi: 10.1016/S0140-6736(18)31116-4. Epub 2018 Jun 13.
Smolen JS, et al. Upadacitinib as monotherapy in patients with active rheumatoid arthritis and inadequate response to methotrexate (SELECT-MONOTHERAPY): a randomised, placebo-controlled, double-blind phase 3 study. Lancet. 2019. May 23. pii: S0140-6736(19)30419-2. doi: 10.1016/S0140-6736(19)30419-2. Epub 2019 May 23.
Fleischmann R, et al. Upadacitinib versus Placebo or Adalimumab in Rheumatoid Arthritis: Results of a Phase 3, Double-Blind, Randomized Controlled Trial. Arthritis and Rheumatology. 2019. Jul 9. doi: 10.1002/art.41032.
van Vollenhoven R, et al. A Phase 3, Randomized, Controlled Trial Comparing Upadacitinib Monotherapy to MTX Monotherapy in MTX-Naïve Patients with Active Rheumatoid Arthritis. 2018 ACR/ARHP Annual Meeting; 891.
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A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of ABT-494 for the Induction of Symptomatic and Endoscopic Remission in Subjects With Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or Are Intolerant to Immunomodulators or Anti-TNF Therapy. ClinicalTrials.gov. 2019. Available at: https://clinicaltrials.gov/ct2/show/NCT02365649. Accessed on October 16, 2019.
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