Tildrakizumab-asmn (Ilumya), an injectable interleukin-23 (IL-23) inhibitor, was approved by the FDA in March for adults who are candidates for systemic therapy or phototherapy.
Sun Pharma announced the availability of its treatment for moderate-to-severe plaque psoriasis in the United States, according to a company press release.
Tildrakizumab-asmn (Ilumya), an injectable interleukin-23 (IL-23) inhibitor, was approved by the FDA in March for adults who are candidates for systemic therapy or phototherapy. The approval was based on data from the phase 3 reSURFACE clinical development program. Tildrakizumab-asmn is indicated at a dose of 100-mg administered as a subcutaneous injection every 12 weeks, following initial doses at weeks 0 and 4, Sun Pharma reported.
In a pooled analysis of phase 3 studies, data showed that tildrakizumab-asmn demonstrated sustained clinical benefit over a 3-year period and was well-tolerated among patients who were treated. Overall, 9 of 10 patients who achieved 75% PASI75 skin clearance at week 28 after 3 doses of tildrakizumab-asmn 100 mg mainatained their skin clearance after 3 years of treatment, according to the data. Additionally, skin clearance was sustained long-term in 67.6% of patients who had reached PASI 90 after 3 doses.
The most common adverse events include upper respiratory infections, injection site reactions, and diarrhea.
“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,” study investigator Dr Andrew Blauvelt, board-certified dermatologist and president of Oregon Medical Research Center, said in a statement.
Analyses presented at the Academy of Managed Care Pharmacy Nexus 2018 determined that tildrakizumab-asmn is among the most cost-effective options compared with non-targeted treatments, according to the press release. Tildrakizumab-asmn was also found to be more cost-effective than other biologic options, including secukinumab, guselkumab, ixekizumab, adalimumab, ustekinumab, and etanercept.
“The availability of Ilumya is an important milestone for Sun Pharma as we expand our specialty medicine portfolio in the US,” Abhay Gandhi, chief executive officer of Sun Pharma, North America, said in the release. “Ilumya offers a new, safe and effective treatment option for people who are still struggling to manage their moderate-to-severe plaque psoriasis.”
Sun Pharma Announces the Availability of ILUMYATM (tildrakizumab-asmn) in the United States for the Treatment of Moderate-to-Severe Plaque Psoriasis [news release]. Sun Pharma website. http://www.sunpharma.com/media/press-releases. Accessed October 25, 2018.