Sun Pharmaceutical Industries announced that USFDA has accepted BLA for tildrakizumab submitted by Merck & Co., USA. The FDA filing acceptance follows acceptance of the regulatory filing of tildrakizumab by EMA in March 2017.
Tildrakizumab is an investigational IL-23p19 inhibitor being evaluated for the treatment of moderate-to-severe plaque psoriasis.
Sun Pharma CEO – North America Business, Abhay Gandhi said that at Sun Dermatology, they are committed to making a difference in the lives of patients and healthcare providers. The acceptance of the regulatory filing by the USFDA marks a significant milestone as they seek to advance for tildrakizumab as a potential new treatment option for people who continue to struggle everyday with the chronic nature of psoriasis.
The BLA filing for tildrakizumab with the USFDA is based on two pivotal Phase III trials (reSURFACE 1 and 2) which included over 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.