NORTH CHICAGO, Ill.,
April 23, 2019 /PRNewswire/ -- AbbVie
(NYSE: ABBV), a research-based global biopharmaceutical company,
today announced that the U.S. Food and Drug Administration (FDA)
approved SKYRIZI™ (risankizumab-rzaa), an interleukin-23 (IL-23)
inhibitor, for the treatment of moderate to severe plaque psoriasis
in adults who are candidates for systemic therapy or
phototherapy.3 In clinical trials, SKYRIZI produced high
rates of durable skin clearance – most people (82 and 81 percent)
treated with SKYRIZI achieved 90 percent skin clearance (PASI 90)
at one year, with the majority (56 and 60 percent) achieving
complete skin clearance (PASI 100).1
"The complex nature of psoriasis and the variability or loss of
treatment response over time can prevent some patients from
achieving their treatment goals," said Kenneth B. Gordon, M.D., a principal
investigator for the ultIMMa-1 pivotal trial and professor and
chair of dermatology at the Medical College of
Wisconsin. "In clinical trials, risankizumab demonstrated
high levels of skin clearance that persisted through one year. I'm
pleased the dermatology community now has a new option that can
help patients achieve and maintain a high level of treatment
response."
The recommended dose for SKYRIZI is 150mg – administered by two
subcutaneous injections every 12 weeks following two initiation
doses at week 0 and 4. SKYRIZI can be administered in-office or by
self-injection after training.3
"The approval of SKYRIZI is an important advance in the
treatment of adults with plaque psoriasis who are seeking high
levels of durable skin clearance that can be maintained over time,"
said Michael Severino, M.D., vice
chairman and president, AbbVie. "SKYRIZI builds on AbbVie's legacy
in immunology, expanding our portfolio to help meet the evolving
needs in psoriatic disease and reinforcing our continued pursuit of
innovations that improve care for people living with
immune-mediated conditions."
Affecting 7.5 million Americans, psoriasis is the most prevalent
autoimmune disease in the U.S.4 It is characterized by
over activation of the immune system and widespread inflammation
that causes painful, itchy plaques anywhere on the
skin.5 People with psoriasis also experience a
significant emotional, psychological and social burden that can
negatively impact their quality of life.4
"People living with plaque psoriasis can be profoundly impacted
by their disease both physically and emotionally," said
Stacie Bell, Ph.D., vice president
of research and medical affairs, National Psoriasis Foundation.
"The approval of a new therapy represents an important step forward
in the treatment of psoriasis, offering dermatologists another
option to help patients achieve their treatment goals."
The approval of SKYRIZI is supported by results from AbbVie's
global Phase 3 psoriasis program, which assessed the safety and
efficacy of SKYRIZI in adults with moderate to severe plaque
psoriasis across four randomized, placebo and/or active-controlled
pivotal studies: ultIMMa-1, ultIMMa-2, IMMhance and IMMvent. The
co-primary endpoints of these studies were Psoriasis Area and
Severity Index (PASI 90) and static Physician Global Assessment
[sPGA] score of clear or almost clear [sPGA 0/1] at 16 weeks versus
placebo.1-3,6
Highlights across the pivotal studies
include:1,3
- In ultIMMa-1 and ultIMMa-2 at 16 weeks, PASI 90 was achieved in
75 percent of people treated with SKYRIZI, compared to 5 and 2
percent receiving placebo, respectively (p<0.001). PASI 100 was
achieved in 36 and 51 percent of people treated with SKYRIZI,
compared to 0 and 2 percent receiving placebo, respectively
(p<0.001).
- In ultIMMa-1 and ultIMMa-2 at one year (52 weeks), 82 and 81
percent of people treated with SKYRIZI achieved PASI 90, and 56 and
60 percent achieved PASI 100, respectively (p<0.001).
- An integrated analysis of ultIMMa-1 and ultIMMa-2 showed most
people treated with SKYRIZI who achieved PASI 90 and PASI 100 at
week 16 maintained this response at one year (88 and 80 percent,
respectively).
The frequency of adverse events through one year was similar to
events observed during the first 16 weeks. The most common adverse
events associated with SKYRIZI included upper respiratory
infections (13 percent), headache (3.5 percent), fatigue (2.5
percent), injection site reactions (1.5 percent) and tinea
infections (1.1 percent). SKYRIZI requires an initial evaluation
for tuberculosis (TB) prior to starting treatment, and patients are
instructed to report signs and symptoms of
infection.3
More information about the psoriasis clinical program can be
found on www.clinicaltrials.gov (NCT02684370, NCT02684357,
NCT02672852, NCT02694523).
SKYRIZI is part of a collaboration between Boehringer Ingelheim
and AbbVie, with AbbVie leading development and commercialization
of SKYRIZI globally.
AbbVie recently received approval of SKYRIZI from the Japanese
Ministry of Health, Labour and Welfare (MHLW) for the treatment of
plaque psoriasis, generalized pustular psoriasis, erythrodermic
psoriasis and psoriatic arthritis, as well as from Health Canada
for the treatment of moderate to severe plaque psoriasis in adults
who are candidates for systemic therapy or phototherapy. AbbVie
also received a positive opinion from the European Medicines
Agency's (EMA) Committee for Medicinal Products for Human Use
(CHMP) recommending marketing authorization for SKYRIZI for the
treatment of moderate to severe plaque psoriasis in adults who are
candidates for systemic therapy, with a regulatory decision in
Europe expected in the first half
of this year.
More information on SKYRIZI, including full prescribing
information, will be available for healthcare professionals soon at
www.skyrizihcp.com.
About SKYRIZI3
SKYRIZI is an interleukin-23 (IL-23) inhibitor that selectively
blocks IL-23 by binding to its p19 subunit. IL-23, a cytokine
involved in inflammatory processes, is thought to be linked to a
number of chronic immune-mediated diseases, including
psoriasis.7
SKYRIZI is approved in the U.S. and Canada for the treatment of moderate to severe
plaque psoriasis in adults who are candidates for systemic therapy
or phototherapy, and in Japan for
the treatment of plaque psoriasis, generalized pustular psoriasis,
erythrodermic psoriasis and psoriatic arthritis in adult patients
who have an inadequate response to conventional therapies. A
marketing authorization application (MAA) for SKYRIZI for the
treatment of patients with moderate to severe plaque psoriasis was
submitted to the European Medicines Agency (EMA) in May 2018 and is currently under evaluation.
Phase 3 trials of SKYRIZI in Crohn's disease and psoriatic
arthritis are ongoing, and it is also being investigated to treat
ulcerative colitis.8-12
Full prescribing information, including medication guide, can be
found here.
SKYRIZI U.S. Use and Important Safety
Information3
SKYRIZI™ is a prescription medicine used to treat adults with
moderate to severe plaque psoriasis who may benefit from taking
injections or pills (systemic therapy) or treatment using
ultraviolet or UV light (phototherapy).
What is the most important information I should know about
SKYRIZI?
SKYRIZI may cause serious side effects,
including infections. SKYRIZI is a prescription medicine that may
lower the ability of your immune system to fight infections and may
increase your risk of infections. Your healthcare provider should
check you for infections and tuberculosis (TB) before starting
treatment with SKYRIZI and may treat you for TB before you begin
treatment with SKYRIZI if you have a history of TB or have active
TB. Your healthcare provider should watch you closely for signs and
symptoms of TB during and after treatment with SKYRIZI.
- Tell your healthcare provider right away if you have an
infection or have symptoms of an infection, including:
-
- fever, sweats, or chills
- muscle aches
- weight loss
- cough
- warm, red, or painful skin or sores on your body different from
your psoriasis
- diarrhea or stomach pain
- shortness of breath
- blood in your mucus (phlegm)
- burning when you urinate or urinating more often than
normal
Before using SKYRIZI, tell your healthcare provider about
all of your medical conditions, including if
you:
- have any of the conditions or symptoms listed in the section
"What is the most important information I should know about
SKYRIZI?"
- have an infection that does not go away or that keeps coming
back.
- have TB or have been in close contact with someone with
TB.
- have recently received or are scheduled to receive an
immunization (vaccine). You should avoid receiving live vaccines
during treatment with SKYRIZI.
- are pregnant or plan to become pregnant. It is not known if
SKYRIZI can harm your unborn baby.
- are breastfeeding or plan to breastfeed. It is not known if
SKYRIZI passes into your breast milk.
Tell your healthcare provider about all the medicines you take,
including prescription and over-the-counter medicines, vitamins,
and herbal supplements.
What are the possible side effects of
SKYRIZI?
SKYRIZI may cause serious side effects. See
"What is the most important information I should know about
SKYRIZI?"
The most common side effects of SKYRIZI include upper
respiratory infections, fungal skin infections, headache, feeling
tired and injection site reactions.
These are not all the possible side effects of SKYRIZI. Call
your doctor for medical advice about side effects.
Use SKYRIZI exactly as your healthcare provider tells you to use
it.
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
- Gordon, K., et al. Efficacy and safety of risankizumab in
moderate-to-severe plaque psoriasis (UltIMMa-1 and UltIMMa-2):
results from two double-blind, randomised, placebo-controlled and
ustekinumab-controlled phase 3 trials. The Lancet. 2018 Aug
25;392(10148):650-661.
- Blauvelt, A., et al. Risankizumab Efficacy/Safety in
Moderate-to-Severe Plaque Psoriasis: 16-Week Results From IMMhance
[abstract P066]. Acta Derm Venereol. 2018; 98(suppl 219): 30.
- SKYRIZI (risankizumab) [Package Insert]. North Chicago, Ill.: AbbVie Inc.
- National Psoriasis Foundation. Statistics.
https://www.psoriasis.org/content/statistics. Accessed March 8, 2019.
- Nature Reviews Disease Primers. Psoriasis. Volume 2. 2016
November. 1-17
- Reich, K., et al. Efficacy and Safety of Risankizumab Compared
with Adalimumab in Patients with Moderate-to-Severe Plaque
Psoriasis: Results from the Phase 3 IMMvent Trial. ePoster #P1813.
European Academy of Dermatology and Venereology Congress.
2018.
- Duvallet, E., Sererano, L., Assier, E., et al. Interleukin-23:
a key cytokine in inflammatory diseases. Ann Med. 2011
Nov;43(7):503-11.
- Pipeline – Our Science | AbbVie. Available at:
https://www.abbvie.com/our-science/pipeline.html. Accessed on
March 8, 2019.
- A Study of the Efficacy and Safety of Risankizumab in Subjects
With Moderately to Severely Active Crohn's Disease.
ClinicalTrials.gov. Available at:
https://clinicaltrials.gov/ct2/show/NCT03105128. Accessed on
March 8, 2019.
- BI 655066/ABBV-066/Risankizumab Compared to Placebo in Patients
With Active Psoriatic Arthritis. ClinicalTrials.gov. Available at:
https://clinicaltrials.gov/ct2/show/NCT02719171. Accessed on
March 8, 2019.
- 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.
Available at: https://www.clinicaltrials.gov/ct2/show/NCT03398135.
Accessed on March 8, 2019.
- 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.
Available at: https://www.clinicaltrials.gov/ct2/show/NCT03398148.
Accessed on March 8, 2019.
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