The drug is indicated to treat moderate-to-severe plaque psoriasis
Sun Pharmaceutical Industries announced that the US Food and Drug Administration (US FDA) has approved ILUMYA (tildrakizumab-asmn) for the treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy. ILUMYA selectively binds to the p19 subunit of IL-23 and inhibits its interaction with the IL-23 receptor leading to inhibition of the release of pro-inflammatory cytokines and chemokines. ILUMYA is administered at a dose of 100 mg by subcutaneous injection every 12 weeks, after the completion of initial doses at weeks 0 and 4. ILUMYA is contraindicated in patients with a previous serious hypersensitivity reaction to tildrakizumab or to any of the excipients.
“With the approval of ILUMYA and our long-standing commitment in dermatology, we are focussed on making a difference for people living with moderate-to-severe plaque psoriasis,” said Abhay Gandhi, President and CEO, North America, Sun Pharma. “We are committed to working with all relevant stakeholders to make ILUMYA™ available to appropriate people with plaque psoriasis.”
The FDA approval of ILUMYA for the treatment of adults with moderate-to-severe plaque psoriasis was supported by data from the pivotal Phase-3 reSURFACE clinical development programme. In the two multicentre, randomised, double-blind, placebo-controlled trials (reSURFACE 1 and reSURFACE 2), 926 adult patients were treated with ILUMYA (N=616) or placebo (N=310). Results from these studies were published in The Lancet in July 2017, with primary endpoints presented at the 25th European Academy of Dermatology and Venereology (EADV) Congress.