Sun Pharmaceutical Industries Inc. Announces Plans to Present 19 Data Abstracts on ILUMYA(TM) for Moderate-to-Severe Plaque Psoriasis at American Academy of Dermatology 2019 Annual Meeting
PRINCETON, N.J., Feb. 27, 2019 /PRNewswire/ -- Sun Pharmaceutical Industries Inc., USA (SPII) today announced that it plans to present 19 abstracts featuring data on ILUMYA(TM) (tildrakizumab-asmn), a prescription medicine used to treat adults with moderate-to-severe plaque psoriasis who are candidates for systemic or phototherapy, at the 77(th) Annual Meeting of the American Academy of Dermatology (AAD) from March 1 - 5 in Washington, DC.
Click to Tweet #NEWS: Sun Pharma announces 19 abstracts on #psoriasis to be presented at #AAD2019.
Data to be presented will offer new clinical insights on the long-term use of ILUMYA(TM) with a 3-year analysis, the impact of ILUMYA(TM) across a range of different patient types including people with common comorbidities such as metabolic syndrome, those previously treated with a biologic and those naïve to biologic therapy, and the safety and cost-effectiveness of ILUMYA(TM).
"These new data will add to the growing body of evidence supporting the benefits of ILUMYA(TM) and provide physicians with additional information needed to treat their moderate-to-severe plaque psoriasis patients," said Abhay Gandhi, President and Chief Executive Officer, Sun Pharmaceutical Industries, Inc. "We are committed to helping people who continue to struggle to manage their psoriasis, both through ongoing research and access support."
ILUMYA(TM) is an injectable interleukin-23 (IL-23) inhibitor approved for the treatment of moderate-to-severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy.(1) ILUMYA(TM) injections are administered by a healthcare provider once every three months, following starter doses at Week 0 and Week 4. Visit www.ILUMYA.com to learn more about the ILUMYA SUPPORT Lighting the Way(TM) program that helps patients get started with treatment, understand cost and saving options, and connect with experts and others living with plaque psoriasis.
The following ILUMYA(TM) data will be presented at AAD 2019:
Abstract Presentation Type
Title
#
--- ---
Long-Term Use of ILUMYA(TM) Over Three Years
---
#10508
E-Poster Efficacy and Safety of Long-term
Tildrakizumab for Plaque Psoriasis: 3-
Year Results From reSURFACE 1
--- ---
#10510
E-Poster Efficacy and Safety of Long-term
Tildrakizumab for Plaque Psoriasis: 3-
Year Results From reSURFACE 2
--- ---
Long-term Efficacy of Tildrakizumab in
Patients with Moderate to Severe
Psoriasis Who Were Nonresponders or
Partial Responders to Etanercept in the
#9754
E-Poster Phase 3 reSURFACE 2 Trial
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Impact of ILUMYA(TM) Across Different Types of Patients
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The Effect of Tildrakizumab on
Cardiometabolic Risk Factors in Psoriasis
by Metabolic Syndrome Status: Post Hoc
Analysis of 2 Phase 3 Trials (reSURFACE 1
#10159 Podium and E-Poster and reSURFACE 2)
--- ---
#9874 Podium and E-Poster Tildrakizumab Efficacy Over Time
Stratified by Week-28 Response Levels
and by Prior Biologic Use
--- ---
#10089 Podium and E-Poster Impact of Body Weight on Efficacy of
Tildrakizumab in Moderate to Severe
Plaque Psoriasis
--- ---
Tildrakizumab Efficacy and Drug Survival
by Metabolic Syndrome Status in
Psoriasis: Post Hoc Analysis of 2 Phase 3
Clinical Studies (reSURFACE 1 and
#10048
E-Poster reSURFACE 2)
--- ---
#10556
E-Poster Safety of Tildrakizumab in Patients with
Pre-existing Metabolic Syndrome: Post
Hoc Analysis of 2 Phase 3 Clinical
Studies (reSURFACE 1 and reSURFACE 2)
--- ---
#10042
E-Poster Efficacy of Tildrakizumab Patient
Subgroups Across a Phase 2b and 2 Phase 3
Trials in Patients with Moderate to
Severe Chronic Plaque Psoriasis
--- ---
Insights on the Safety of
ILUMYA(TM)
---
#9806 Podium and E-Poster Relationships Between Tildrakizumab Dose,
Exposure, Efficacy and Safety in Phase 3
Studies in Moderate to Severe Plaque
Psoriasis
--- ---
Incidence of Cardiovascular Events Among
Tildrakizumab-Treated Patients with
Moderate to Severe Plaque Psoriasis:
Pooled Data From 3 Large Randomized
#9796 Podium and E-Poster Clinical Trials
--- ---
Limited Changes in Hematological
Parameters During Tildrakizumab
Treatment: Post Hoc Analysis of Data from
the Tildrakizumab Psoriasis Clinical
#10549 Podium and E-Poster Program
--- ---
Hypersensitivity and Injection-Site
Reactions in Patients in the
Tildrakizumab Clinical Development
Program: Effect of Antidrug
#9881 Podium and E-Poster Antibody-Positive Status
--- ---
#9753
E-Poster Incidence of Opportunistic Infections in
the Tildrakizumab Psoriasis Clinical
Development Program
--- ---
#9823
E-Poster No Increased Risk of Liver Dysfunction
from Tildrakizumab Treatment: Post Hoc
Analyses of the Tildrakizumab Psoriasis
Clinical Program
--- ---
#9812
E-Poster Outcomes of Pregnancies from Two Large
Tildrakizumab Phase 3 Studies (reSURFACE
1 and reSURFACE 2)
--- ---
ILUMYATM Cost Effectiveness and Quality of Life Impact
---
#8694 Podium and E-Poster Cost-effectiveness of Tildrakizumab in
U.S. Patients with Moderate-to-Severe
Plaque Psoriasis
--- ---
#8251
E-Poster Comparative Cost per Time in Response for
Tildrakizumab in U.S. Patients with
Moderate-to-Severe Plaque Psoriasis
--- ---
Tildrakizumab Results in Significant and
Sustained Improvements in Health-Related
Quality of Life in Patients with Moderate
to Severe Psoriasis in a Phase 3 Trial
#8047
E-Poster (reSURFACE 1)
--- ---
Please click here for Full Prescribing Information and Medication Guide.
About ILUMYA(TM) (tildrakizumab-asmn)
ILUMYA(TM) (tildrakizumab-asmn) is a humanized lgG1/k monoclonal antibody designed to selectively bind to the p19 subunit of interleukin-23 (IL-23) and inhibit its interaction with the IL-23 receptor, leading to inhibition of the release of pro-inflammatory cytokines and chemokines.
ILUMYA(TM) is indicated for the treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy. The U.S. Food and Drug Administration approval is based on data from the pivotal Phase-3 reSURFACE clinical development program, which consisted of two randomized, double-blind, placebo-controlled trials of more than 1,800 patients across over 200 clinical trial sites.
ILUMYA(TM) has also been approved in Australia, and in Europe under the brand name ILUMETRI(TM).
IMPORTANT SAFETY INFORMATION
ILUMYA(TM) is contraindicated in patients with a previous serious hypersensitivity reaction to tildrakizumab or to any of the excipients.
Cases of angioedema and urticaria occurred in ILUMYA(TM)-treated subjects in clinical trials. If a serious allergic reaction occurs, discontinue ILUMYA(TM) immediately and initiate appropriate therapy.
ILUMYA(TM) may increase the risk of infection. Treatment with ILUMYA(TM) should not be initiated in patients with a clinically important active infection until the infection resolves or is adequately treated. Consider the risks and benefits of treatment prior to prescribing ILUMYA(TM) in patients with a chronic infection or a history of recurrent infection. Instruct patients receiving ILUMYA(TM) to seek medical help if signs or symptoms of clinically important chronic or acute infection occur. If a patient develops a clinically important or serious infection, or is not responding to standard therapy, closely monitor and consider discontinuation of ILUMYA(TM) until the infection resolves.
Evaluate patients for tuberculosis (TB) infection prior to initiating treatment with ILUMYA(TM). Do not administer ILUMYA(TM) to patients with active TB infection. Initiate treatment of latent TB prior to administering ILUMYA(TM). Consider anti-TB therapy prior to initiation of ILUMYA(TM) in patients with a past history of latent or active TB in whom an adequate course of treatment cannot be confirmed. Patients receiving ILUMYA(TM) should be monitored closely for signs and symptoms of active TB during and after treatment.
Prior to initiating therapy with ILUMYA(TM), consider completion of all age-appropriate immunizations according to current immunization guidelines. Patients treated with ILUMYA(TM) should not receive live vaccines.
The most common (>=1%) adverse reactions associated with ILUMYA(TM) treatment that were more frequent than in the placebo group are upper respiratory infections, injection-site reactions, and diarrhea.
About Psoriasis
Psoriasis is a chronic immune disease that appears on the skin, affecting approximately 8 million Americans(2) and 125 million people worldwide.(3) The non-contagious disorder speeds the growth cycle of skin cells(2) and results in thick scaly areas of skin.(4) The most common form, affecting about 80 to 90 percent of people with psoriasis, is called plaque psoriasis.(5) It appears as red, raised areas of skin covered with flaky white scales which may be itchy and painful and can crack and bleed.(5 )Twenty percent of people with plaque psoriasis are considered moderate-to-severe(5), and many continue to struggle with the ongoing, persistent nature of this chronic disease.
About Sun Dermatology
Sun Dermatology (the branded dermatology division of a wholly owned subsidiary of Sun Pharmaceutical Industries Inc.) is committed to expanding its dermatology portfolio to bring healthcare providers and patients around the world more treatment options and ongoing support for conditions like moderate-to-severe plaque psoriasis. Sun Pharmaceutical Industries Ltd., along with its subsidiaries, is ranked fourth in dermatology prescription volume within the U.S. per IQVIA and is the fifth largest specialty generic pharmaceutical company globally. In addition to ILUMYA(TM), Sun Dermatology is comprised of several branded products with a focus on various dermatologic conditions.
Disclaimer
Statements in this "Document" describing the Company's objectives, projections, estimates, expectations, plans or predictions or industry conditions or events may be "forward looking statements" within the meaning of applicable securities laws and regulations. Actual results, performance or achievements could differ materially from those expressed or implied.
References
1. ILUMYA(TM) PI
2. National Psoriasis Foundation. Facts About Psoriasis. January 2019.
3. National Psoriasis Foundation. Psoriasis Around the World. January 2019.
4. National Psoriasis Foundation. About Psoriasis. January 2019.
5. Menter A, et al. J Am Acad Dermatol. 2008;58(5):826-50.
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