Regulatory Affairs

Sun Pharma gets FDA nod for Ilumya to treat moderate-to-severe plaque psoriasis

PBR Staff Writer Published 22 March 2018

India-based Sun Pharma has secured approval from the US Food and Drug Administration (FDA) for Ilumya (tildrakizumab-asmn) to treat adult patients with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy.

Ilumya 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 approval was based on data from the pivotal phase-3 reSURFACE clinical development program, which included two multicenter, randomized, double-blind and placebo-controlled trials with 926 adult patients.

The phase-3 studies, including reSURFACE 1 and reSURFACE 2, have been designed to show efficacy of Ilumya in moderate-to-severe plaque psoriasis compared to placebo and comparative drug, as well as assess safety and tolerability.

According to the company, both phase-3 studies achieved the primary efficacy endpoints, which showed significant clinical improvement with Ilumya 100mg compared to placebo.

Sun Pharma secured worldwide rights to Ilumya from Merck. Funding for the trials has been provided by Sun Pharma, while Merck is responsible for the completion of phase-3 trials and submission of a biologics license application to the US Food and Drug Administration (FDA).

Merck will also help Sun Pharma in manufacturing finished goods and initial product launch.

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

The company will also take care of all regulatory, pharmacovigilance, post approval studies, manufacturing and commercialization of approved products for all non US markets. Merck is provided with option to secure milestone payments and royalties on sales of Ilumya.

Sun Pharma North America CE and president Abhay Gandhi said: "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.

“We are committed to working with all relevant stakeholders to make Ilumya available to appropriate people with plaque psoriasis."