NORTH CHICAGO, Ill.,
April 25, 2018 /PRNewswire/
-- AbbVie (NYSE: ABBV), a research-based global
biopharmaceutical company, announced that it has submitted a
Biologics License Application (BLA) to the U.S. Food and Drug
Administration for risankizumab, an investigational interleukin-23
(IL-23) inhibitor, being evaluated for treatment of patients with
moderate to severe plaque psoriasis.
"The risankizumab submission represents an important milestone
in our goal of advancing treatment for people living with
immune-mediated diseases," said Michael
Severino, M.D., executive vice president, research and
development and chief scientific officer, AbbVie. "Risankizumab has
the potential to be an important treatment option for people living
with plaque psoriasis and we look forward to working with the FDA
throughout the review process."
The BLA is supported by data from the global risankizumab Phase
3 psoriasis program evaluating more than 2,000 patients with
moderate to severe chronic plaque psoriasis across four Phase 3
studies: ultIMMA-1, ultIMMa-2, IMMhance and IMMvent.1-3
Across all four studies, risankizumab met all co-primary and ranked
secondary endpoints with no new safety signals across the Phase 3
program.1-3 Top-line results of these clinical
studies were previously announced in October and December 2017.
Risankizumab is not approved by regulatory authorities and its
safety and efficacy have not been established.
Risankizumab is part of a collaboration with Boehringer
Ingelheim, with AbbVie leading future development and
commercialization of risankizumab globally.
About the Risankizumab Phase 3 Psoriasis
Program1-3
The global risankizumab Phase 3
psoriasis program evaluates more than 2,000 patients with moderate
to severe plaque psoriasis in four pivotal studies.
The studies include assessments of efficacy, safety and
tolerability of risankizumab. Key measures of efficacy include
measures of disease activity and skin clearance, including PASI 90,
PASI 100 and sPGA 0/1, as well as long-term clinical outcomes. More
information on this program can be found
at www.clinicaltrials.gov (NCT02672852, NCT02694523,
NCT02684370, NCT02684357).
About Risankizumab
Risankizumab is an investigational
compound that is designed to selectively block IL-23 by binding to
its p19 subunit.4 IL-23, a key cytokine involved in
inflammatory processes, is thought to be linked to a number of
chronic immune-mediated diseases.5 Phase 3 trials
of risankizumab in psoriasis and Crohn's disease are ongoing, and
it is also being investigated to treat psoriatic
arthritis.6,7 Future trials are planned to investigate
risankizumab in ulcerative colitis.8,9
Risankizumab is not approved by regulatory authorities. Safety
and efficacy have not been established.
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 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, 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," of AbbVie's 2017 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.
1 Gordon K, et al. Efficacy and Safety of
Risankizumab: Results from Two Double-Blind, Placebo- and
Ustekinumab-Controlled, Phase 3 Trials in Moderate-to-Severe Plaque
Psoriasis. American Academy of Dermatology. February 2018.
2 AbbVie. Data on File, ABVRRTI65374.
3 AbbVie. Data on File, ABVRRTI65055.
4 Papp K.A., et al. Risankizumab versus Ustekinumab for
Moderate-to-Severe Plaque Psoriasis. NEJM. 2017.
5 Duvallet E, Sererano L, Assier E, et. al.
Interleukin-23: a key cytokine in inflammatory diseases. Ann Med.
2011 Nov;43(7):503-11.
6 A Study of the Efficacy and Safety of
Risankizumab in Subjects With Moderately to Severely Active Crohn's
Disease. ClinicalTrials.gov. 2018. Available
at: https://clinicaltrials.gov/ct2/show/NCT03105128. Accessed
on February 2, 2018.
7 BI 655066/ABBV-066/Risankizumab Compared to
Placebo in Patients With Active Psoriatic Arthritis.
ClinicalTrials.gov. 2018. Available
at: https://clinicaltrials.gov/ct2/show/NCT02719171. Accessed
on February 2, 2018.
8 A Study to Assess the Efficacy and Safety of
Risankizumab in Subjects With Ulcerative Colitis Who Responded to
Induction Treatment in M16-067 or M16-065. ClinicalTrials.gov.
2018. https://www.clinicaltrials.gov/ct2/show/NCT03398135.
Accessed on February 2, 2018.
9 A Study to Evaluate the Efficacy and Safety of
Risankizumab in Subjects With Moderately to Severely Active
Ulcerative Colitis Who Have Failed Prior Biologic Therapy.
ClinicalTrials.gov.
2018. https://www.clinicaltrials.gov/ct2/show/NCT03398148.
Accessed on February 2, 2018.
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SOURCE AbbVie