NORTH CHICAGO, Ill.,
Jan. 8, 2018 /PRNewswire/ -- AbbVie
(NYSE: ABBV), a global research and development-based
biopharmaceutical company, today announced the U.S. Food and Drug
Administration (FDA) granted Breakthrough Therapy Designation for
the investigational, once-daily oral JAK1-selective inhibitor
upadacitinib (ABT-494) in adult patients with moderate to severe
atopic dermatitis who are candidates for systemic therapy. This
Breakthrough Therapy Designation is supported by positive Phase
2b results previously announced in
September 2017,11 and
marks 13 Breakthrough Therapy
Designations granted to AbbVie's investigational treatments since
the company's inception in 2013. Upadacitinib is not approved by
regulatory authorities and its safety and efficacy have not been
established.
Atopic dermatitis, a chronic inflammatory skin disease, is
characterized by skin erosion, oozing and crusting, redness,
intense itching (pruritus) and dry skin.12 Symptoms can
appear as a rash on the skin, or the skin may become thickened and
leathery.13
The FDA's Breakthrough Therapy Designation program is intended
to expedite the development and review of medicines with
preliminary clinical evidence that indicate that the
investigational treatment may demonstrate substantial improvement
over existing therapies on one or more clinically significant
endpoints.1
"Our history, scientific expertise and leadership in immunology
drive our focus to develop new treatment approaches that address
urgent and unmet needs," said Michael
Severino, M.D., executive vice president, research and
development and chief scientific officer, AbbVie. "Current
treatment options for people living with atopic dermatitis are
limited, and addressing these patient needs is important to us. We
look forward to advancing upadacitinib into Phase 3 studies for
atopic dermatitis soon."
In the U.S. alone, atopic dermatitis affects an estimated 28
million people of all ages, and can have a significant impact on
the physical and psychosocial health of
patients.10,14-16
AbbVie will present additional data from the Phase 2b trial at upcoming scientific congresses.
Additional information on the clinical trials for upadacitinib is
available at www.clinicaltrials.gov.
About Upadacitinib
Discovered and developed by AbbVie,
upadacitinib is an investigational oral agent engineered to
selectively inhibit JAK1, which plays an important role in the
pathophysiology of immune-mediated
disorders.2,3 Phase 3 trials of upadacitinib in
rheumatoid arthritis, psoriatic arthritis and Crohn's disease are
ongoing and it is also being investigated to treat ulcerative
colitis, ankylosing spondylitis and atopic
dermatitis.4-9
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 or LinkedIn.
Forward-Looking Statements
Some statements in this
news release may be 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, challenges to intellectual property,
competition from other products, 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," in
AbbVie's 2016 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
1 U.S. Food and Drug
Administration. Fact Sheet: Breakthrough Therapies.
https://www.fda.gov/RegulatoryInformation/LawsEnforcedbyFDA/SignificantAmendmentstotheFDCAct/FDASIA/ucm329491.htm.
Accessed January 3, 2018.
2 Voss, J, et al; Pharmacodynamics Of a Novel Jak1
Selective Inhibitor In Rat Arthritis and Anemia Models and In
Healthy Human Subjects. [abstract]. Arthritis Rheum 2013;65 Suppl
10 :2374. DOI: 10.1002/art.2013.65.issue-s10
3 Pipeline – Our Science | AbbVie. AbbVie. 2017.
Available at: https://www.abbvie.com/our-science/pipeline.html.
Accessed January 3, 2018.
4 A Study Comparing ABT494 to Placebo in Subjects With
Rheumatoid Arthritis on a Stable Dose of Conventional Synthetic
Disease Modifying Antirheumatic Drugs (csDMARDs) Who Have an
Inadequate Response to csDMARDs Alone (SELECT-NEXT) - Full Text
View - ClinicalTrials.gov. Clinicaltrialsgov. 2018. Available at:
https://clinicaltrials.gov/ct2/show/NCT02675426. Accessed on
January 3, 2018.
5 A Study Comparing 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). Clinicaltrialsgov. 2018.
Available at:
https://clinicaltrials.gov/ct2/show/NCT03104400?term=ABT-494&phase=2&rank=10.
Accessed on January 3, 2018.
6 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 - Full
Text View - ClinicalTrials.gov. Clinicaltrialsgov. 2018. Available
at: https://clinicaltrials.gov/ct2/show/NCT02365649. Accessed on
January 3, 2018.
7 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. Clinicaltrialsgov. 2018.
Available at: https://clinicaltrials.gov/ct2/show/NCT02819635.
Accessed on January 3, 2018.
8 A Study Evaluating the Safety and Efficacy of
Upadacitinib in Subjects With Active Ankylosing Spondylitis (SELECT
Axis 1). 2018. Available
at: https://clinicaltrials.gov/ct2/show/study/NCT03178487?term=ABT-494&cond=ankylosing+spondylitis&rank=1.
Accessed on January 3, 2018.
9 A Study to Evaluate ABT-494 in Adult Subjects With
Moderate to Severe Atopic Dermatitis. Clinicaltrialsgov. 2018.
Available at: https://clinicaltrials.gov/ct2/show/NCT02925117.
Accessed on January 3, 2018.
10 American Academy of Dermatology. "Eczema." Available
at: https://www.aad.org/media/stats/conditions/eczema. Accessed on
January 3, 2018.
11 AbbVie Data on File. Upadacitinib AD Phase
2b Press Release 05SEPT2017.
12 Simon Francis Thomsen.
Atopic Dermatitis: Natural History, Diagnosis, and Treatment. ISRN
Allergy.doi:10.1155/2014/354250.
13 Williams HC. Clinical practice. Atopic dermatitis. N
Engl J Med. 2005;352(22):2314-24.
14 Eichenfield LF, Tom WL, Chamlin SL, et al. Guidelines
of care for the management of atopic dermatitis: section 1.
Diagnosis and assessment of atopic dermatitis. J Am Acad Dermatol.
2014;70:338-51.
15 Thyssen JP, Hamann CR, et al. Atopic dermatitis is
associated with anxiety, depression, and suicidal ideation, but not
with psychiatric hospitalization or suicide. Allergy. 2018
Jan;73(1):214-220. doi: 10.1111/all.13231. Epub 2017 Aug 2.
16 Gupta MA, Gupta AK. Psychiatric and psychological
co-morbidity in patients with dermatologic disorders. Am J Clin
Dermatol. 2003;4(12):833-42.
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SOURCE AbbVie