Breaking News
April 21, 2018 - Americans world’s biggest TV addicts, watching four hours a day
April 21, 2018 - Investigational drug may help increase protein levels in babies with spinal muscular atrophy
April 21, 2018 - Study shows distinctions between age groups in predicting and responding to stress at home
April 21, 2018 - Aziyo Biologics, BIOTRONIK enter into US co-distribution agreement
April 21, 2018 - Opiate Use Linked to Early Mortality in IBD Patients
April 21, 2018 - Online ads help pregnant smokers quit
April 21, 2018 - Opioid pain medications may not be safe for hemodialysis patients
April 21, 2018 - Rare variants in non-coding DNA inherited from parents heighten autism risk
April 21, 2018 - A needleless glucose monitor for diabetes patients
April 21, 2018 - BD introduces new informatics and automation solutions for clinical laboratories
April 21, 2018 - Turn Chores Into a Fitness Routine
April 21, 2018 - DNA methylation plays key role in stem cell differentiation
April 21, 2018 - Scientists find link between soil metals and cancer mortality
April 21, 2018 - Experts discuss implications of low calcium intake in global population
April 21, 2018 - GNA Biosolutions to display Pharos V8 Laser PCR instrument at Analytica trade fair
April 21, 2018 - People with vitamin D deficiency may be at greater risk of diabetes
April 21, 2018 - Study findings could open new possibilities for treating cancer with adenovirus
April 21, 2018 - People who use medical marijuana have higher rates of prescription drug use, study finds
April 21, 2018 - Study debunks ‘myth’ that strenuous exercise dampens immunity
April 21, 2018 - FDA approves marijuana based medication for epilepsy treatment
April 21, 2018 - Researchers find novel genes for longevity in mammals
April 21, 2018 - GNA Biosolutions and project partners launch new research project to develop TB diagnostic platform for POC applications
April 21, 2018 - Scientists identify gene responsible for evolution of recombination rates
April 21, 2018 - UConn researchers develop new composite for healing broken load-bearing bones
April 21, 2018 - Study challenges use of whole-brain radiation for small-cell lung cancer patients with brain metastases
April 21, 2018 - People who become physically active after heart attack more likely to live longer, shows research
April 21, 2018 - CPRIT awards $2 million grant to push forward breast cancer research in West Texas
April 21, 2018 - Unhealthy diet damages the development of immature fat cells, study shows
April 21, 2018 - Consumption of protein supplements with meals may provide better weight control
April 21, 2018 - 4 Types of Foods to Help Boost Your Memory
April 21, 2018 - How did gonorrhea become a drug-resistant superbug?
April 21, 2018 - DePuy Synthes announces clinical results related to use of CORAIL Hip System Femoral Stems
April 21, 2018 - New initiative launched to support goals of Human Cell Atlas
April 20, 2018 - Teen patient gets a new lease on life
April 20, 2018 - Cancer Australia launches new framework to improve outcomes for lung cancer patients
April 20, 2018 - ‘Gut-on-a-chip’ model recreates intestinal matrix critical for nutrient absorption
April 20, 2018 - Researchers develop new drug-testing platform for epilepsy
April 20, 2018 - FDA Alert: NxtGen Botanicals Maeng Da Kratom by NGB Corp.: Recall
April 20, 2018 - Pelizaeus-Merzbacher-like disease type 1 – Genetics Home Reference
April 20, 2018 - Tick-borne diseases reach epidemic levels, panel says
April 20, 2018 - A potential “male pill” without side effects
April 20, 2018 - Researchers discover new information related to rare form of leukemia
April 20, 2018 - Researchers find crucial links between dopamine and avoidance behavior
April 20, 2018 - UGA scientist creates system for efficient detection of foodborne pathogens
April 20, 2018 - Social Support of Autonomy Tied to Better Glycemic Control in DM
April 20, 2018 - Study reports use of nutritional ketosis with mobile app intervention could reverse Type 2 diabetes
April 20, 2018 - New microscopy techniques allow quasi-biochemical studies on living T cells
April 20, 2018 - Study shows connection between muscular strength and brain health
April 20, 2018 - Ecolab introduces Life Sciences cleanroom program in North America
April 20, 2018 - Normal weight people with fat belly may have more chance of heart problems
April 20, 2018 - Male fruit flies like sex and alcohol
April 20, 2018 - Meditation could help reduce anxiety levels and some heart health risk factors
April 20, 2018 - Improving job prospects unlikely to control opioid epidemic
April 20, 2018 - Skin Sensor Might Someday Track Alcoholics’ Booze Intake
April 20, 2018 - The relevance of GABA for diabetes highlighted in two new studies
April 20, 2018 - Novel method enables fast and noninvasive assessment of tumor status
April 20, 2018 - IU psychologist receives NIH grant to study earliest phases of language learning in children
April 20, 2018 - Walking fast lowers risk of hospitalization in heart patients, shows study
April 20, 2018 - Study reveals surprising insights into RNA-binding proteins
April 20, 2018 - Young victims of cyberbullying twice as likely to attempt suicide and enact suicidal behavior
April 20, 2018 - Role of UBE3A enzyme in Angelman syndrome
April 20, 2018 - NovaDigm Therapeutics initiates NDV-3A Phase 2a study for reduction of S. aureus in military trainees
April 20, 2018 - High-tech microscope reveals how cancer-causing virus anchors itself to human DNA
April 20, 2018 - Experimental compound reduces destructive inflammation to improve stroke outcome
April 20, 2018 - The May issue of Drug Discovery Today is a Special Issue and will be published very soon
April 20, 2018 - Larger families linked to heightened tooth loss risk for moms
April 20, 2018 - Scientists develop tiny fluorescent probe that seeks out GLUT5 and detects cancer cells
April 20, 2018 - The Swedish Childhood Cancer Foundation awards grant to KI researchers
April 20, 2018 - AMSBIO’s MC-Easy minicircle technology allows sustained transgene expression in quiescent cells and tissues
April 20, 2018 - Researchers use optogenetics to treat chronic pain
April 20, 2018 - Discovery of 100 new genes may aid research into pigmentation
April 20, 2018 - AYOXXA introduces new LUNARIS Mouse 12-Plex Th17 Kit for quantitative analysis of Th17 cell biology
April 20, 2018 - Compound derived from immune cells treats psoriasis in mice
April 20, 2018 - GABA-transaminase deficiency – Genetics Home Reference
April 20, 2018 - Key heart risks decline for older Americans
April 20, 2018 - UD professor wins $2.3 million grant from NIH for research on Achilles tendinopathy
April 20, 2018 - Researchers discover unique protein in malaria parasite that could be new drug target
April 20, 2018 - Bio-Techne expands automation capabilities of popular RNAscope ISH technology
April 20, 2018 - Smartphone app effective in promoting proper child car seat practices
April 20, 2018 - Nutraceuticals could play an important role in preventing heart disease
FDA Approves Ilumya (tildrakizumab-asmn) for the Treatment of Moderate-to-Severe Plaque Psoriasis

FDA Approves Ilumya (tildrakizumab-asmn) for the Treatment of Moderate-to-Severe Plaque Psoriasis

image_pdfDownload PDFimage_print

FDA Approves Ilumya (tildrakizumab-asmn) for the Treatment of Moderate-to-Severe Plaque Psoriasis

MUMBAI, India and PRINCETON, N.J., March 21, 2018 /PRNewswire/ — Sun Pharmaceutical Industries Ltd. today announced that the U.S. Food and Drug Administration (FDA) has approved Ilumya (tildrakizumab-asmn) for the treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy. Ilumya selectively binds to the p19 subunit of IL-23 and inhibits its interaction with the IL-23 receptor leading to inhibition of the release of pro-inflammatory cytokines and chemokines. Ilumya is administered at a dose of 100 mg by subcutaneous injection every 12 weeks, after the completion of initial doses at weeks 0 and 4. Ilumya is contraindicated in patients with a previous serious hypersensitivity reaction to tildrakizumab or to any of the excipients.

“With the approval of Ilumya and our long-standing commitment in dermatology, we are focused on making a difference for people living with moderate-to-severe plaque psoriasis,” said Abhay Gandhi, President and Chief Executive Officer, North America, Sun Pharma. “We are committed to working with all relevant stakeholders to make Ilumya available to appropriate people with plaque psoriasis.”

The FDA approval of Ilumya for the treatment of adults with moderate-to-severe plaque psoriasis was supported by data from the pivotal Phase-3 reSURFACE clinical development program. In the two multicenter, randomized, double-blind, placebo-controlled trials (reSURFACE 1 and reSURFACE 2), 926 adult patients were treated with Ilumya (N=616) or placebo (N=310). Results from these studies were published in The Lancet in July 2017, with primary endpoints presented at the 25th European Academy of Dermatology and Venereology (EADV) Congress.

Both Phase-3 studies met the primary efficacy endpoints, demonstrating significant clinical improvement with Ilumya 100 mg compared to placebo when measured by at least 75 percent of skin clearance (Psoriasis Area Sensitivity Index or PASI 75) and Physician’s Global Assessment (PGA) score of “clear” or “minimal” at week 12 after two doses.

Of the patients in the reSURFACE 1 study 74 percent (229 patients) achieved 75 percent skin clearance at week 28 after three doses, and 84 percent of patients who continued receiving Ilumya 100 mg maintained PASI 75 at week 64 compared to 22 percent of patients who were re-randomized to placebo. In addition, 69 percent of the patients receiving Ilumya 100 mg who had a PGA score of “clear” or “minimal” at week 28 maintained this response at week 64 compared to 14 percent of patients who were re-randomized to placebo.

IMPORTANT SAFETY INFORMATION

Cases of angioedema and urticaria occurred in Ilumya treated subjects in clinical trial. If a serious hypersensitivity reaction occurs, discontinue Ilumya immediately and initiate appropriate therapy.

Ilumya may increase the risk of infection. Treatment with Ilumya 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 in patients with a chronic infection or a history of recurrent infection. Instruct patients receiving Ilumya 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 discontinue Ilumya until the infection resolves.

Evaluate patients for TB infection prior to initiating treatment with Ilumya. Initiate treatment of latent TB prior to administering Ilumya. Monitor patients for signs and symptoms of active TB during and after Ilumya treatment. Do not administer Ilumya to patients with active TB infection.

Prior to initiating Ilumya, consider completion of all age-appropriate immunizations according to current immunization guidelines. Avoid use of live vaccines in patients treated with Ilumya.

The most common (≥1%) adverse reactions associated with Ilumya include upper respiratory infections, injection site reactions, and diarrhea. Adverse reactions that occurred at rates less than 1% but greater than 0.1% in the Ilumya group and at a higher rate than in the placebo group included dizziness and pain in extremity.

About the Phase-3 reSURFACE Trials

The Phase-3 studies (reSURFACE 1 and reSURFACE 2) were randomized, placebo-controlled, multicenter, three-part studies designed to demonstrate efficacy of Ilumya in moderate-to-severe plaque psoriasis compared to placebo and comparative drug and to assess safety and tolerability. Part one of the studies randomized patients into three or four treatment arms, including Ilumya 100 mg, ILUMYA 200 mg, placebo and etanercept (reSURFACE 2 only). After Week 12, patients on placebo were then re-randomized into Ilumya 100 mg and 200 mg treatment arms to proceed into part two of the studies. Finally, in part three of the reSURFACE 1 study, responders (PASI ≥75) and partial responders (PASI ≥50 and PASI

About Psoriasis

Psoriasis is a chronic immune disease that appears on the skin. It is a non-contagious disorder that speeds the growth cycle of skin cells1 and results in thick scaly areas of skin2. The most common form, affecting about 80 to 90 percent of people living with psoriasis, is called plaque psoriasis3. It appears as red, raised areas of skin covered with flaky white scales, which may be itchy and painful and can crack and bleed2. Many people with plaque psoriasis 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 Pharma) 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 Pharma, along with its subsidiaries, is ranked fourth in dermatology prescription volume within the U.S. per IMS and is fifth largest specialty generic pharmaceutical company globally. In addition to Ilumya, Sun Dermatology is comprised of several branded products indicated for the treatment of acne and actinic keratosis with a focus on other dermatologic conditions.

About Sun Pharma, Merck & Co., Inc., Kenilworth, NJ, USA, Agreement

Sun Pharmaceutical Industries Ltd.’s wholly owned subsidiary licensed worldwide rights to Ilumya from a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA, in 2014. Funded by a Sun Pharma subsidiary, Merck & Co., Inc., Kenilworth, NJ, USA was responsible for the completion of Phase-3 trials and submission of a Biologics License Application to the United States Food and Drug Administration (FDA), as well as manufacturing finished goods to support Sun Pharma’s initial product launch. Sun Pharma will be responsible for all post-approval regulatory activities, including subsequent submissions, pharmacovigilance, post approval studies, manufacturing and commercialization of the approved product. Sun Pharma will also be responsible for all regulatory, pharmacovigilance, post approval studies, manufacturing and commercialization of approved products for all non-U.S. markets. Merck & Co., Inc., Kenilworth, NJ, USA is eligible to receive milestone payments and royalties on sales of Ilumya.

About Sun Pharma, Almirall S.A, Europe, Agreement

Sun Pharma and its wholly owned subsidiary and Almirall (Spanish Stock Exchange ticker: ALM) closed on July 2016 a licensing agreement on the development and commercialization of tildrakizumab-asmn for psoriasis in Europe. Under the terms of the licensing agreement, Almirall is able to lead European studies, and participate in larger Global clinical studies for plaque psoriasis indication subject to the terms of the Sun Pharma – Merck & Co., Inc., Kenilworth, NJ, USA agreements, as well as certain cost sharing agreements. Sun Pharma will be eligible to receive development and regulatory milestone payments and, additionally, sales milestone payments and royalties on net sales. Sun Pharma will continue to lead development of tildrakizumab-asmn for other indications, where Almirall will have right of first negotiation for certain indications in Europe. The agreement between Sun Pharma and Almirall remains subject to the exclusive licensing agreement between Sun Pharma and Merck & Co., Inc., Kenilworth, NJ, USA.

About Sun Pharmaceutical Industries Ltd.

Sun Pharma is the world’s fifth largest specialty generic pharmaceutical company and India’s top pharmaceutical company. A vertically integrated business, economies of scale and an extremely skilled team enable us to deliver quality products in a timely manner at affordable prices. It provides high-quality, affordable medicines trusted by customers and patients in over 150 countries across the world. Sun Pharma’s global presence is supported by 41 manufacturing facilities spread across 6 continents, R&D centres across the globe and a multi-cultural workforce comprising over 50 nationalities. In India, the company enjoys leadership across 11 different classes of doctors with 30 brands featuring amongst top 300 pharmaceutical brands in India. Its footprint across emerging markets covers over 100 markets and 6 markets in Western Europe. Its Global Consumer Healthcare business is ranked amongst Top 10 across 3 global markets. Its API business footprint is strengthened through 14 world class API manufacturing facilities across the globe. Sun Pharma fosters excellence through innovation supported by strong R&D capabilities comprising about 2,000 scientists and R&D investments of approximately 8% of annual revenues. For further information, please visit www.sunpharma.com & follow us on Twitter @SunPharma_Live.

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. National Psoriasis Foundation. Facts about psoriasis. www.psoriasis.org/sites/default/files/for-media/MediaKit.pdf. Accessed on February 22, 2018.
2. National Psoriasis Foundation. About Psoriasis. www.psoriasis.org/about-psoriasis.
Accessed on February 22, 2018.
3. Menter A, Gottlieb A, Feldman SR, Van Voorhees AS et al. Guidelines of care for the management of psoriasis and psoriatic arthritis: Section 1. Overview of psoriasis and guidelines of care for the treatment of psoriasis with biologics. J Am Acad Dermatol 2008 May; 58(5):826-50.

SOURCE Sun Pharma

Posted: March 2018

Related Articles:

Ilumya (tildrakizumab-asmn) FDA Approval History

Tagged with:

About author

Related Articles