The United States Food and Drug Administration (FDA) has approved India-based Sun Pharma's Ilumya (tildrakizumab-asmn) intended to treat adult patients with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy, it was reported yesterday.

The product selectively adheres to the p19 subunit of IL-23 and suppresses its interaction with the IL-23 receptor to inhibit release of pro-inflammatory cytokines and chemokines. It will be administered at a dose of 100mg by subcutaneous injection every 12 weeks, after completing initial doses between zero and four.

The product received approval based on data from the pivotal phase-three reSURFACE clinical development program, which included two multicentre, randomised, double-blind and placebo-controlled trials with 926 adult patients. The phase-three studies, including reSURFACE 1 and reSURFACE 2, have been designed to indicate efficacy of Ilumya in moderate-to-severe plaque psoriasis compared to placebo and comparative drug, and evaluate safety and tolerability. According to the company, both phase-three studies achieved the primary efficacy endpoints, which indicated significant clinical improvement with Ilumya 100mg compared to placebo.

Sun Pharma obtained worldwide Ilumya rights from Merck. Sun Pharma has provided funding for the trials, while Merck is responsible for the completion of phase-3 trials and submission of a biologics license application to the US FDA. Merck will also help Sun Pharma in manufacturing finished goods and in the initial product launch.

Sun Pharma will take responsibility for all post-approval regulatory activities, including subsequent submissions, pharmacovigilance, post approval studies, manufacturing and commercialisation of the approved product.