Ilumya™ (tildrakizumab-asmn) 100mg/mL from Sun Pharmaceutical Industries Ltd. is now available in the United States. Ilumya 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.Ilumya injections are administered by a healthcare provider every 12 weeks, following starter doses at Week 0 and Week 4.

"The availability of Ilumya is an important milestone for Sun Pharma as we expand our specialty medicine portfolio in the US. Ilumya 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 Ilumya among 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," says Mary Robinson, a tildrakizumab clinical trial participant. "After a couple doses of Ilumya 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 Ilumya 100mg/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.Most common (≥1%) adverse reactions associated with Ilumya 100 mg treatment are upper respiratory infections, infection site reactions, and diarrhea.

"We saw that nine out of 10 patients who achieved 75 percent skin clearance, or PASI 75, at Week 28 after three doses of Ilumya 100mg 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 Ilumya," says 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 Ilumya 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 Ilumya as a first-line treatment. The data results demonstrated that Ilumya is among the most cost-effective options compared to non-targeted treatments such as apremilast. Furthermore, Ilumya was more cost-effective than other biologic options including secukinumab, guselkumab, ixekizumab, adalimumab, ustekinumab and etanercept.

Sun Pharma says it is working closely with relevant stakeholders to ensure Ilumya is accessible to patients with moderate-to-severe psoriasis across the US who may benefit from this new treatment option.