Tildrakizumab BLA filing accepted by FDA

The US Food and Drug Administration has accepted the Biologics License Application (BLA) for tildrakizumab from Indian drug major Sun Pharmaceutical Industries (BSE: 524715).

The FDA filing acceptance follows the acceptance of the regulatory submission of tildrakizumab by the European Medicines Agency (EMA) in March this year. In Europe, Spain’s Almirall (ALM: MC) has been granted development and commercialization rights to the drug by Sun Pharma.

Tildrakizumab is 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 (NYSE: MRK), which out-licensed the drug to Sun Pharma in 2014 in exchange for an upfront payment of $80 million.

According to Abhay Gandhi, chief executive, North America Business, Sun Pharma, “At Sun dermatology, we are committed to making a difference in the lives of patients and healthcare providers. The acceptance of the regulatory filing by the US 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.”

Clinical backing

The BLA filing for tildrakizumab with the US FDA 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.