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.1-5,7
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.
About the SELECT Study Program1-5
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.
- Bergman M, et al. Upadacitinib Treatment and the Routine
Assessment of Patient Index Data 3 (RAPID3) Among Patients with
Rheumatoid Arthritis. 2019 ACR/ARHP Annual Meeting; 551.
- Cohen S, et al. Safety profile of upadacitinib in Rheumatoid
Arthritis: Integrated analysis from the SELECT Phase 3 Clinical
Program. EULAR 2019; THU0167.
- Pipeline – Our Science | AbbVie. AbbVie. 2019. Available at:
https://www.abbvie.com/our-science/pipeline.html. Accessed on
October 16, 2019.
- A Phase 3 Study to Compare ABT-494 to Abatacept in Subjects
With Rheumatoid Arthritis on Stable Dose of Conventional Synthetic
Disease-Modifying Antirheumatic Drugs (csDMARDs) Who Have an
Inadequate Response or Intolerance to Biologic DMARDs
(SELECT-CHOICE). Clinicaltrials.gov. 2019. Available at:
https://clinicaltrials.gov/ct2/show/NCT03086343. Accessed on
October 16, 2019.
- A Study Comparing Upadacitinib (ABT-494) to Placebo and to
Adalimumab in Participants With Psoriatic Arthritis Who Have an
Inadequate Response to at Least One Non-Biologic Disease Modifying
Anti-Rheumatic Drug (SELECT - PsA 1). ClinicalTrials.gov. 2019.
Available at: https://clinicaltrials.gov/ct2/show/NCT03104400.
Accessed on October 16, 2019.
- A Study Comparing Upadacitinib (ABT-494) to Placebo in
Participants With Active Psoriatic Arthritis Who Have a History of
Inadequate Response to at Least One Biologic Disease Modifying
Anti-Rheumatic Drug (SELECT - PsA 2). 2019. Available at:
https://clinicaltrials.gov/ct2/show/NCT03104374. Accessed on
October 16, 2019.
- 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.
- Evaluation of Upadacitinib in Adolescent and Adult Patients
With Moderate to Severe Atopic Dermatitis (Eczema)- Measure Up 1.
ClinicalTrials.gov. 2019. Available at:
https://clinicaltrials.gov/ct2/show/NCT03569293. Accessed on
October 16, 2019.
- A Study to Evaluate the Safety and Efficacy of ABT-494 for
Induction and Maintenance Therapy in Subjects With Moderately to
Severely Active Ulcerative Colitis. ClinicalTrials.gov. 2019.
Available at: https://clinicaltrials.gov/ct2/show/NCT02819635.
Accessed on October 16, 2019.
- A Study Evaluating the Safety and Efficacy of Upadacitinib in
Subjects With Active Ankylosing Spondylitis (SELECT Axis 1).
ClinicalTrials.gov. 2019. Available at:
https://clinicaltrials.gov/ct2/show/study/NCT03178487. Accessed on
October 16, 2019.
- A Study to Evaluate the Safety and Efficacy of Upadacitinib in
Participants With Giant Cell Arteritis (SELECT-GCA).
ClinicalTrials.gov. 2019. Available at:
https://clinicaltrials.gov/ct2/show/NCT03725202. Accessed on
October 16, 2019.
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