Sun Pharmaceutical Industries Ltd. has announced that moderate-to-severe psoriasis treatment ILUMYATM (tildrakizumab-asmn) 100 mg/mL is now available in the United States. ILUMYATM is an injectable interleukin-23 (IL-23) inhibitor approved by the FDA for the treatment of moderate-to-severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy.1ILUMYATM injections are administered by a healthcare provider every 12 weeks, following starter doses at Week 0 and Week 4.
“The availability of ILUMYATM is an important milestone for Sun Pharma as we expand our specialty medicine portfolio in the U.S. ILUMYATM offers a new, safe and effective treatment option for people who are still struggling to manage their moderate-to-severe plaque psoriasis,” said Abhay Gandhi, Chief Executive Officer, Sun Pharma, North America. “We understand the importance of patient and physician choice, and are committed to making ILUMYATMamong the most cost-effective treatments on the market today.” “For nearly 20 years, my psoriasis has disrupted my life in many ways. I never imagined the impact of dealing with flaking and peeling skin,” said Mary Robinson, a tildrakizumab clinical trial participant. “After a couple doses of ILUMYATM my skin started to improve, and I’m encouraged by the ongoing results that help me keep my psoriasis under control.” A pooled analysis of the Phase-3 studies presented recently at the European Academy of Dermatology and Venerology (EADV) Congress demonstrated the clinical results of ILUMYATM 100 mg/mL were sustained over a three-year period, and the medicine was well-tolerated with very low drug-related serious adverse events and discontinuation rates.2 Most common (≥1%) adverse reactions associated with ILUMYA™ 100 mg treatment are upper respiratory infections, infection site reactions, and diarrhea.1 “We saw that nine out of 10 patients who achieved 75 percent skin clearance, or PASI 75, at Week 28 after three doses of ILUMYATM 100 mg maintained their skin clearance after three years on treatment. Skin clearance was also sustained over the long-term in 67.6 percent of patients who had reached PASI 90 after the first three doses of ILUMYATM,” said study investigator Dr. Andrew Blauvelt, board-certified dermatologist and President of Oregon Medical Research Center. “These long-term data tell us that quarterly maintenance dosing of ILUMYATM offers clinically meaningful benefits over time, which is promising news for patients and clinicians.” Additional analyses presented today at Academy of Managed Care Pharmacy (AMCP) Nexus 2018 used the 10-year Markov model to demonstrate the cost-effectiveness of ILUMYATM as a first-line treatment. The data results demonstrated that ILUMYATM is among the most cost-effective options compared to non-targeted treatments such as apremilast. Furthermore, ILUMYATM was more cost-effective than other biologic options including secukinumab, guselkumab, ixekizumab, adalimumab, ustekinumab and etanercept.3,4 Sun Pharma is working closely with relevant stakeholders to ensure ILUMYATMis accessible to patients with moderate-to-severe psoriasis across the U.S. who may benefit from this new treatment option.
About Psoriasis Psoriasis is a chronic immune disease that appears on the skin, affecting approximately 8 million Americans5 and 125 million people worldwide6. The non-contagious disorder speeds the growth cycle of skin cells5 and results in thick scaly areas of skin7. The most common form, affecting about 80 to 90 percent of people with psoriasis, is called plaque psoriasis8. It appears as red, raised areas of skin covered with flaky white scales which may be itchy and painful and can crack and bleed7. Twenty percent of people with plaque psoriasis are considered moderate-to-severe and many continue to struggle with the ongoing, persistent nature of this chronic disease.