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Sun Pharma received US FDA acceptance of BLA for Tildrakizumab


Tildrakizumab is being evaluated for treatment of moderate-to-severe plaque psoriasis

Sun Pharma announces the US FDA acceptance of the Biologics License Application (BLA) for tildrakizumab. 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. The BLA filing for tildrakizumab was submitted by Merck.

According to Abhay Gandhi, CEO – North America Business, Sun Pharma, “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.”

The BLA filing for tildrakizumab with the US FDA is based on two pivotal Phase III trials (reSURFACE I and II) 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.

Reportedly, future presentations and publications of the reSURFACE phase-III pivotal trials will include more scientific insights on the data to week 52 and beyond. The clinical trials are designed to evaluate safety and efficacy for up to five years, and to date, some clinical trial participants have been treated with tildrakizumab for up to three and half years.

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