FDA accepts biologics license application for tildrakizumab for treating psoriasis

Sun Pharma announced that the FDA has accepted a biologics license application for tildrakizumab for treating moderate-to-severe plaque psoriasis.

Merck & Co. filed the biologics license application (BLA) for tildrakizumab, an investigational humanized, anti-IL-23p19 monoclonal antibody designed to selectively block the cytokine IL-23. Sun Pharmaceutical Industries Ltd.'s subsidiary acquired worldwide rights to tildrakizumab from Merck in 2014, according to a news release.

The filing was based on two phase 3 randomized, placebo-controlled, multicenter, three-part studies trials of more than 1,800 patients with moderate-to-severe plaque psoriasis, including some who had been treated with tildrakiuzmab for more than 3 years. The trials are designed to measure safety and efficacy for up to 5 years, according to the release.

Patients were initially randomized into three or four treatment arms, including tildrakizumab 200 mg, tildrakizumab 100 mg, placebo and Enbrel (etanercept, Amgen).

Trial data was presented at the American Academy of Dermatology Annual Meeting in March in Orlando. Future scientific presentations will include data to 52 weeks and beyond, according to the release.

Funded by a Sun Pharma subsidiary, Merck is responsible for the completion of phase 3 trials in patients with mild-to-moderate plaque psoriasis and submission of the BLA, according to the release.

The FDA action follows the European Medicines Agency’s acceptance of the regulatory filing of tildrakizumab in March.

Reference: www.sunpharma.com