US FDA accepts application of Sun Pharma's partner Merck for tildrakizumab

Sun Pharmaceutical Industries Ltd has announced that the US Food and Drug Administration (FDA) has accepted the biologics license application (BLA) for tildrakizumab filed by its partner, Merck & Co Inc. The US 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. 

In 2014, Sun Pharma acquired worldwide rights to tildrakizumab from Merck, known as MSD outside the US and Canada. Funded by a Sun Pharma subsidiary, Merck is responsible for the completion of