New Delhi: Drug major Sun Pharmaceutical Industries on Wednesday said the US health regulator has accepted biologics licence application (BLA) for tildrakizumab for the treatment of psoriasis.
“The FDA filing acceptance follows the acceptance of the regulatory filing of tildrakizumab by the European Medicines Agency (EMA) in March 2017. Tildrakizumab is an investigational IL-23p19 inhibitor being evaluated for the treatment of moderate-to-severe plaque psoriasis,” Sun Pharma said in a regulatory filing.
Sun Pharma’s North America Business chief executive officer Abhay Gandhi said: “The acceptance of the regulatory filing by the USFDA marks a significant milestone as we 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 company said that the BLA filing for tildrakizumab with the US FDA is based on two pivotal Phase III trials 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.
The BLA filing for tildrakizumab was submitted by Merck & Co., Inc., Kenilworth, NJ, USA, it added. The BLA is a request for permission to introduce, or deliver for introduction, a biologic product into interstate commerce, as per the USFDA. Shares of Sun Pharma were trading 0.23% higher at Rs613.95 on BSE.