Sun Pharma wins US FDA approval for ILUMYA (tildrakizumab-asmn) for the treatment of Plaque Psoriasis
22 March 2018 -

Generic pharmaceutical company Sun Pharmaceutical Industries Ltd (Reuters:SUN.BO)(Bloomberg:SUNP IN)(NSE:SUNPHARMA)(BSE:524715) reported on Wednesday the receipt of approval from the US Food and Drug Administration (FDA) for ILUMYA (tildrakizumab-asmn) for the treatment of plaque psoriasis.

The company said ILUMYA (tildrakizumab-asmn) is indicated for the treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy following the successful pivotal Phase-3 reSURFACE clinical development programme.

Under the company's two multicentre, randomized, double-blind, placebo-controlled trials (reSURFACE 1 and reSURFACE 2), 926 adult patients were treated with ILUMYA or placebo.

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% of skin clearance and Physician's Global Assessment score of "clear" or "minimal" at week 12 after two doses, added the company.

According to the company, 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. It is administered at a dose of 100 mg by subcutaneous injection every 12 weeks.