Sun Pharma: FDA Approves Ilumya for Adult Psoriasis

The FDA has approved Ilumya™ (tildrakizumab-asmn) from Sun Pharma 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 100mg 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 focused on making a difference for people living with moderate-to-severe plaque psoriasis," said Abhay Gandhi, President and Chief Executive Officer, 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 program. In the two multicenter, randomized, 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.

Both Phase-3 studies met the primary efficacy endpoints, demonstrating significant clinical improvement with Ilumya 100 mg compared to placebo when measured by at least 75 percent of skin clearance (Psoriasis Area Sensitivity Index or PASI 75) and Physician's Global Assessment (PGA) score of "clear" or "minimal" at week 12 after two doses.

Of patients in the reSURFACE 1 study, 74 percent (229 patients) achieved 75 percent skin clearance at week 28 after three doses, and 84 percent of patients who continued receiving Ilumya 100mg maintained PASI 75 at week 64 compared to 22 percent of patients who were re-randomized to placebo. In addition, 69 percent of the patients receiving Ilumya 100mg who had a PGA score of "clear" or "minimal" at week 28 maintained this response at week 64 compared to 14 percent of patients who were re-randomized to placebo.