Separate Phase 3 Analysis Highlights Long-Term Safety Profile
of SILIQ
LAVAL, Quebec, Feb. 16, 2018 /CNW/ -- Ortho Dermatologics, a
division of Valeant Pharmaceuticals North America, LLC (NYSE: VRX
and TSX: VRX), today announced results from an analysis of the
Phase 3 clinical trial AMAGINE-1, which evaluated mental health
comorbidities associated with psoriasis, such as anxiety and
depression. These findings were presented for the first time at the
76th Annual Meeting of the American Academy of
Dermatology (AAD), Feb. 16-20, 2018,
in San Diego.
"Anxiety and depression occur more frequently among patients
with psoriasis than the general population," said Dr. Melinda Gooderham, medical director at the SKiN
Centre for Dermatology in Peterborough,
Ontario. "The data from AMAGINE-1 demonstrated that patients
who switched from placebo to SILIQ had lower scores for
disease-related anxiety and depression."
Also presented at the meeting was a pooled analysis of the
Pivotal Phase 3 clinical trials AMAGINE-1, -2 and -3, which
demonstrated that the safety profile of SILIQ at year two of
treatment for patients with moderate-to-severe psoriasis was
similar to its safety profile at year one of treatment. In total,
15 abstracts, including six oral presentations and nine poster
presentations, will be presented on SILIQ.
SILIQ is indicated for the treatment of moderate-to-severe
plaque psoriasis in adult patients who are candidates for systemic
therapy or phototherapy and have failed to respond or have lost
response to other systemic therapies. SILIQ has a Black Box Warning
and a Risk Evaluation and Mitigation Strategy (REMS) due to
observed suicidal ideation and behavior in clinical trials. SILIQ
is contraindicated in patients with Crohn's disease. Serious
infections have occurred; therefore caution should be exercised
when considering the use of SILIQ in patients with a chronic
infection or a history of recurrent infection. Patients should be
evaluated for tuberculosis infection prior to initiating treatment
and avoid use of live vaccines.i
Plaque psoriasis is the most common type of psoriasis, a
chronic, noncommunicable skin disease that alters the life cycle of
skin cells, causing them to build up rapidly on the surface of the
skin.ii,iii,iv It is associated with serious
comorbidities and substantial impairment of physical and
psychological quality of life.4
"The robust research being presented at AAD continues to deepen
our understanding of the potential of SILIQ and reinforces our
commitment to addressing patient needs," said Bill Humphries, executive vice president of
Dermatology, Ortho Dermatologics. "Plaque psoriasis is a chronic
condition that often requires lifelong management, and we are
encouraged by the consistent safety profile of SILIQ during the
second year of treatment."
Summary of Results
Effects of Brodalumab on Anxiety and Depression in Patients
With Psoriasis: Results From a Phase 3, Randomized, Controlled
Clinical Trial
Results from the Phase 3, randomized,
controlled clinical trial AMAGINE-1 suggested that treatment with
SILIQ reduced anxiety and depression in patients with
moderate-to-severe plaque psoriasis. In the study, hospital anxiety
and depression scale (HADS) scores were measured at baseline and at
12, 24, 36 and 52 weeks in patients treated with SILIQ (210 mg) or
placebo. After 12 weeks of SILIQ treatment, patients experienced a
decrease in depression and anxiety HADS scores (mean scores
decreased by 2.1 and 1.8, respectively) while scores remained
unaffected in those receiving placebo. Improvement in depression
and anxiety HADS scores were also seen in patients who switched
from placebo to SILIQ after a 12 week induction phase (mean scores
decreased by 2.3 and 1.7, respectively), but worsened in patients
who switched from SILIQ to placebo.
Long-term Safety of Brodalumab for the Treatment of
Moderate-to-Severe Psoriasis: 2-Year Data From 3 Pivotal Phase 3
Clinical Trials
Results from a pooled analysis of three
double-blind, placebo-controlled, Phase 3 clinical trials
(AMAGINE-1, -2, and -3) demonstrated that the safety profile of
SILIQ in patients with moderate-to-severe plaque psoriasis during
the second year of treatment was similar to that of the first year
of treatment. Additionally, no unexpected safety signals emerged.
The analysis evaluated 3,708 patients who received any dose of
SILIQ in the long-term, open-label extension studies of the three
trials. Overall, in the second year of treatment, the most common
treatment-emergent adverse events were joint pain (n=196), headache
(n=155) and candida infections (n=111), and one fatal
treatment-emergent adverse event (cardiac arrest) occurred.
About SILIQ
In February
2017, the U.S. Food and Drug Administration (FDA) approved
the Biologics License Application for SILIQ, a novel human
monoclonal antibody that binds to the interleukin-17 (IL-17)
receptor A and inhibits inflammatory signaling by preventing the
binding of several types of IL-17 to the receptor. By blocking
IL-17 from activating the receptor, SILIQ prevents the body from
receiving signals that may lead to inflammation. The IL-17 pathway
plays a central role in inducing and promoting inflammatory disease
processes. LEO Pharma currently holds exclusive rights to develop
and commercialize brodalumab in Europe, and Valeant holds the license to
develop and commercialize SILIQ in the U.S and other territories,
other than Japan and certain other
Asian countries.
About Ortho Dermatologics
Ortho Dermatologics, a
Valeant Pharmaceuticals International, Inc. company, is one of the
largest prescription dermatology businesses in the world dedicated
to helping patients in the treatment of a range of therapeutic
areas including actinic keratosis, acne, atopic dermatitis, cold
sores, athlete's foot, nail fungus and other dermatoses. The Ortho
Dermatologics portfolio includes several leading acne, anti-fungal
and anti-infective products. More information can be found at
www.ortho-dermatologics.com.
Important Safety Information
What is the most important information I should know about
SILIQ?
Suicidal thoughts or behavior: Some
patients taking SILIQ have had suicidal thoughts or ended their own
lives. This risk is higher if you have a history of suicidal
thoughts or depression. It is not known if SILIQ causes these
thoughts or actions. Get medical help right away if you or a family
member notices that you have any of the following symptoms:
- new or worsening depression, anxiety, or mood problems
- thoughts of suicide, dying, or hurting yourself
- attempt to commit suicide, or acting on dangerous impulses
- other unusual changes in your behavior or mood
Your healthcare provider will give you a SILIQ patient/wallet
card about symptoms that need medical attention right away. Carry
the card with you during treatment with SILIQ and show it to all of
your healthcare providers.
Serious Infections: SILIQ 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 tuberculosis (TB)
before starting treatment with SILIQ and may treat you for TB
before starting SILIQ if you have TB or a history of it
- You and your healthcare provider need to watch closely for
signs and symptoms of infection during treatment with SILIQ,
including fever, sweats, chills, shortness of breath, stomach
issues, muscle aches, cough, sore throat or trouble swallowing,
warm/red painful skin sores, burning while urinating or more
frequent urination
Who should not use SILIQ?
Do not use SILIQ if you have
Crohn's disease. Tell your healthcare provider if you develop
diarrhea, bloody stools, stomach pain or cramping, sudden or
uncontrollable bowel movements, loss of appetite, constipation,
weight loss, fever or tiredness as these may be symptoms of Crohn's
disease.
Before starting SILIQ, tell your healthcare provider if
you:
- have a history of mental health problems, including suicidal
thoughts, depression, anxiety, or mood problems
- have an infection that does not go away or 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 getting live vaccines
while being treated with SILIQ
- are or plan to become pregnant, or are breastfeeding or plan to
do so. It is unknown if SILIQ can harm your unborn or newborn
baby
Tell your healthcare provider about all the medicines you take,
including prescription and over-the-counter medicines, vitamins,
and herbal supplements.
How should I use SILIQ?
See the detailed
"Instructions for Use" that come with your SILIQ for
information on the right way to store, prepare, and give your SILIQ
injections at home, and how to properly throw away (dispose of)
used SILIQ prefilled syringes. Use SILIQ exactly as your healthcare
provider tells you to use it.
What are possible side effects of SILIQ?
SILIQ may
cause serious side effects. See "What is the most important
information I should know about SILIQ?" and "Who should not take
SILIQ?"
The most common side effects of SILIQ
include:
Joint pain
Headache
Tiredness
Diarrhea
Mouth or throat pain
Nausea
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Muscle pain
Injection site reactions
Flu
Low white blood cell count
(neutropenia)
Fungal infections of the skin
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Call your doctor for medical advice on side effects. You are
encouraged to report negative side effects of prescription drugs to
FDA at www.fda.gov/MedWatch or call
1-800-FDA-1088.
Click here for full Prescribing Information, including Black Box
Warning about suicidal ideation and behavior.
About Valeant
Valeant Pharmaceuticals International,
Inc. (NYSE/TSX: VRX) is a multinational specialty pharmaceutical
company that develops, manufactures and markets a broad range of
pharmaceutical products primarily in the areas of dermatology,
gastrointestinal disorders, eye health, neurology and branded
generics. More information about Valeant can be found at
www.valeant.com.
Forward-looking Statements
This press release may
contain forward-looking statements which may generally be
identified by the use of the words "anticipates, "expects,"
"intends," "plans," "should," "could," "would," "may," "will,"
"believes," "estimates," "potential," "target," or "continue" and
variations or similar expressions. These statements are based upon
the current expectations and beliefs of management and are subject
to certain risks and uncertainties that could cause actual results
to differ materially from those described in the forward-looking
statements. These risks and uncertainties include, but are not
limited to, risks and uncertainties discussed in the Company's most
recent annual or quarterly report and detailed from time to time in
Valeant's other filings with the Securities and Exchange Commission
and the Canadian Securities Administrators, which factors are
incorporated herein by reference. Readers are cautioned not to
place undue reliance on any of these forward-looking statements.
These forward-looking statements speak only as of the date hereof.
Valeant undertakes no obligation to update any of these
forward-looking statements to reflect events or circumstances after
the date of this press release or to reflect actual outcomes,
unless required by law.
SILIQ is a trademark of Valeant Pharmaceuticals
International, Inc. or its affiliates.
Any
other product/brand names are trademarks of the respective
owners.
© 2018 Valeant Pharmaceuticals North America
LLC
i SILIQTM label.
ii National Psoriasis Foundation. (2014). About Psoriasis.
Retrieved from
https://www.psoriasis.org/about-psoriasis. Accessed
February 6, 2018.
iii World Health Organization. (2016). Psoriasis. Retrieved
from
http://www.who.int/ncds/management/psoriasis/en/.
Accessed February 6, 2018.
iv Mayo Clinic. (2017). Psoriasis. Retrieved from
https://www.mayoclinic.org/diseases-conditions/psoriasis/symptoms-causes/syc-20355840.
Accessed February 6, 2018.
Contact
Information:
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Media
Contact:
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Arthur
Shannon
|
Lainie
Keller
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514-856-3855
|
908-927-0617
|
877-281-6642 (toll
free)
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SOURCE Valeant Pharmaceuticals International, Inc.