Drug major Sun Pharmaceutical Industries Ltd. today said the U.S. health regulator has accepted biologics licence application for Tildrakizumab for the treatment of psoriasis.
"The Food and Drug Administration 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.
The acceptance of the regulatory filing by the U.S. FDA 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.Abhay Gandhi, CEO - North America, Sun Pharmaceuticals
The company said that the biologics licence application filing for Tildrakizumab with the U.S. 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 filing for tildrakizumab was submitted by Merck & Co., it added.
The biologics licence application is a request for permission to introduce, or deliver for introduction, a biologic product into interstate commerce, as per the U.S. FDA.
The Sun Pharma stock, which had fallen as much as 1.2 percent to 606.6, erased losses after the announcement.