Sun Pharma Announces US FDA Filing Acceptance of Biologics License Application For Tildrakizumab

The U.S. Food and Drug Administration (FDA) has accepted the Biologics License Application (BLA) for Sun Pharma’s tildrakizumab, an investigational IL-23p19 inhibitor being evaluated for the treatment of moderate-to-severe plaque psoriasis.

The BLA filing for tildrakizumab was submitted by Merck & Co., Inc., Kenilworth, NJ, USA. Sun Pharmaceutical Industries Ltd.'s wholly owned subsidiary acquired worldwide rights to tildrakizumab from Merck (through a Merck subsidiary), known as MSD outside the United States and Canada, in 2014.

The news follows acceptance of the regulatory filing of tildrakizumab by the European Medicines Agency (EMA) in March 2017.

The BLA filing for tildrakizumab with the U.S. FDA is based on two pivotal Phase III trials (reSURFACE 1 and 2) which included more than 1,800 patients across more than 200 clinical trial sites, including some patients who have been treated with tildrakizumab for up to three and a half years. Data from these trials were most recently presented at the 2017 American Academy of Dermatology (AAD) Annual Meeting in March and previously presented at the 25th European Academy of Dermatology and Venereology Congress. Future presentations and publications of the reSURFACE Phase-3 pivotal trials will include more scientific insights on the data to week 52 and beyond. The clinical trials are designed to evaluate safety and efficacy for up to five years, and to date, some clinical trial participants have been treated with tildrakizumab for up to three and half years.