FDA Approves New Psoriasis Drug
The US Food and Drug Administration (FDA) has approved ILUMYA (tildrakizumab-asmn) for the treatment of adults with moderate to severe plaque psoriasis who are eligible for systemic therapy or phototherapy.
The approval was granted following the completion of the phase 3 reSURFACE clinical development program, during which 926 adult patients with moderate to severe plaque psoriasis were treated with either ILUMYA (n = 616) or placebo (n = 310).
A dose of 100 mg of ILUMYA demonstrated significant clinical improvement vs placebo.
Upper respiratory infections, injection site reactions, and diarrhea were the most commonly reported adverse events associated with ILUMYA. Patients with a serious hypersensitivity to tildrakizumab and/or a clinically important active infection should not use ILUMYA.
Sun Pharma announces U.S. FDA approval of ILUMYA (tildrakizumab-asmn) for the treatment of moderate-to-severe plaque psoriasis [press release]. Mumbai, India, and Princeton, NJ. SunPharma. March 21, 2018. https://www.prnewswire.com/news-releases/sun-pharma-announces-us-fda-approval-of-ilumya-tildrakizumab-asmn-for-the-treatment-of-moderate-to-severe-plaque-psoriasis-300617454.html. Accessed on March 21, 2018.