NORTH CHICAGO, Ill.,
Feb. 28, 2022 /PRNewswire/
-- AbbVie (NYSE: ABBV) today announced that the U.S. Food and
Drug Administration (FDA) has extended its review period for
SKYRIZI® (risankizumab-rzaa) for the treatment of
moderate to severe Crohn's disease in patients 16 years and
older.
The FDA has extended the Prescription Drug User Fee Act (PDUFA)
action date by three months to review additional data submitted by
AbbVie, including information about the on-body injector, for this
new proposed indication. Currently approved indications for SKYRIZI
are not affected by this extension.
SKYRIZI was approved in the U.S. in 2019 to treat moderate to
severe plaque psoriasis in adults who are candidates for systemic
therapy or phototherapy. Earlier this year, the FDA approved
SKYRIZI to treat active psoriatic arthritis in
adults.1
SKYRIZI is part of a collaboration between Boehringer Ingelheim
and AbbVie, with AbbVie leading development and commercialization
of SKYRIZI globally.
About SKYRIZI® (risankizumab-rzaa)
SKYRIZI
is an interleukin-23 (IL-23) inhibitor that selectively blocks
IL-23 by binding to its p19 subunit.1,2 IL-23, a
cytokine involved in inflammatory processes, is thought to be
linked to a number of chronic immune-mediated diseases, including
psoriasis.2 SKYRIZI is approved in the U.S. to
treat moderate to severe plaque psoriasis in adults who are
candidates for systemic therapy or phototherapy, as well as to
treat active psoriatic arthritis in adults.1 Phase 3
trials of SKYRIZI in psoriasis, Crohn's disease, ulcerative colitis
and psoriatic arthritis are ongoing.3-11
SKYRIZI U.S. Uses and Important Safety
Information1
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).
- Active psoriatic arthritis (PsA).
What is the most important information I should know about
SKYRIZI® (risankizumab-rzaa)?
SKYRIZI is a prescription medication that may cause serious
side effects, including:
Serious Allergic Reactions: Stop using SKYRIZI and
get emergency help right away if you get any of the following
symptoms of serious allergic reaction:
- Fainting, dizziness, feeling lightheaded (low blood
pressure)
- Swelling of your face, eyelids, lips, mouth, tongue, or
throat
- Trouble breathing or throat tightness
- Chest tightness
- Skin rash, hives
- Itching
Infections: SKYRIZI 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
Do not use SKYRIZI if you are allergic to
risankizumab-rzaa or any of the ingredients in SKYRIZI.
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). Medications that interact with the immune
system may increase your risk of getting an infection after
receiving live vaccines. You should avoid receiving live vaccines
right before, during, or right after treatment with SKYRIZI. Tell
your healthcare provider that you are taking SKYRIZI before
receiving a vaccine.
- 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, feeling tired, fungal skin infections,
headache, 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.
SKYRIZI is available in a 150 mg/mL prefilled syringe and
pen.
This is the most important information to know about SKYRIZI.
For more information, talk to your HCP.
You are encouraged to report negative side effects of
prescription drugs to the FDA.
Visit http://www.fda.gov/medwatch or call
1-800-FDA-1088.
If you are having difficulty paying for your medicine, AbbVie
may be able to help.
Visit AbbVie.com/myAbbVieAssist to learn
more.
Please click here for the Full Prescribing
Information and Medication
Guide for SKYRIZI.
Globally, prescribing information varies; refer to the
individual country product label for complete information.
About AbbVie
AbbVie's mission is to discover and
deliver innovative medicines that solve serious health
issues today and address the medical challenges of tomorrow.
We strive to have a remarkable impact on people's lives across
several key therapeutic areas: immunology, oncology, neuroscience,
eye care, virology, women's health and gastroenterology, in
addition to products and services across its Allergan Aesthetics
portfolio. 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, failure to realize
the expected benefits from AbbVie's acquisition of Allergan plc
("Allergan"), failure to promptly and effectively integrate
Allergan's businesses, competition from other products, challenges
to intellectual property, difficulties inherent in the research and
development process, adverse litigation or government action,
changes to laws and regulations applicable to our industry and the
impact of public health outbreaks, epidemics or pandemics, such as
COVID-19. 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 2021 Annual Report on Form 10-K, which has been filed with
the Securities and Exchange Commission, as updated by its
subsequent Quarterly Reports on Form 10-Q. 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:
- SKYRIZI (risankizumab) [Package Insert]. North Chicago, Ill.: AbbVie Inc.
- Duvallet, E., Sererano, L., Assier, E., et al. Interleukin-23:
a key cytokine in inflammatory diseases. Ann Med. 2011
Nov;43(7):503-11.
- BI 655066 (Risankizumab) Compared to Placebo and Active
Comparator (Ustekinumab) in Patients With Moderate to Severe
Chronic Plaque Psoriasis. ClinicalTrials.gov. 2021. Available at:
https://clinicaltrials.gov/ct2/show/NCT02684370. Accessed on
February 25, 2022.
- BI 655066 Versus Placebo & Active Comparator (Ustekinumab)
in Patients With Moderate to Severe Chronic Plaque Psoriasis.
ClinicalTrials.gov. 2021. Available at:
https://clinicaltrials.gov/ct2/show/NCT02684357. Accessed on
February 25, 2022.
- BI 655066 / ABBV-066 (Risankizumab) in Moderate to Severe
Plaque Psoriasis With Randomized Withdrawal and Re-treatment.
ClinicalTrials.gov. 2021. Available at:
https://clinicaltrials.gov/ct2/show/NCT02672852. Accessed on
February 25, 2022.
- BI 655066/ABBV-066 (Risankizumab) Compared to Active Comparator
(Adalimumab) in Patients With Moderate to Severe Chronic Plaque
Psoriasis. ClinicalTrials.gov. 2021. Available at:
https://clinicaltrials.gov/ct2/show/NCT02694523. Accessed on
February 25, 2022.
- A Study of the Efficacy and Safety of Risankizumab in
Participants With Moderately to Severely Active Crohn's Disease.
ClinicalTrials.gov. 2021. Available at:
https://clinicaltrials.gov/ct2/show/NCT03105128. Accessed on
February 25, 2022.
- A Study to Assess the Efficacy and Safety of Risankizumab in
Participants With Ulcerative Colitis. ClinicalTrials.gov. 2021.
Available at: https://clinicaltrials.gov/ct2/show/NCT03398135.
Accessed on February 25, 2022.
- A Multicenter, Randomized, Double-Blind, Placebo Controlled
Induction Study to Evaluate the Efficacy and Safety of Risankizumab
in Participants With Moderately to Severely Active Ulcerative
Colitis. Available at:
https://clinicaltrials.gov/ct2/show/NCT03398148. Accessed on
February 25, 2022.
- BI 655066/ABBV-066/Risankizumab Compared to Placebo in Patients
With Active Psoriatic Arthritis. Available at:
https://clinicaltrials.gov/ct2/show/NCT03675308. Accessed on
February 25, 2022.
- BI 655066/ABBV-066/ A Study Comparing Risankizumab to Placebo
in Participants With Active Psoriatic Arthritis Including Those Who
Have a History of Inadequate Response or Intolerance to Biologic
Therapy(Ies). Available
at: https://clinicaltrials.gov/ct2/show/NCT03671148. Accessed
on February 25, 2022.
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SOURCE AbbVie