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Sun Pharma to create drug used for treatment of psoriasis, gets USFDA's nod

Regulatory filing by FDA marks a significant milestone to advance for tildrakizumab: Sun Pharma Ceo

Press Trust of India  |  New Delhi 


Drug major Sun Pharmaceutical Industries today said the US health regulator has accepted biologics licence application (BLA) for for the treatment of psoriasis.

"The FDA filing acceptance follows the acceptance of the regulatory filing of by the European Medicines Agency (EMA) in March 2017. 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 CEO -North America Business Abhay Gandhi said: "The acceptance of the regulatory filing by the marks a significant milestone as we seek to advance for as a potential new treatment option for people who continue to struggle everyday with the chronic nature of psoriasis".

The company said that the filing for with the 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 for up to three-and-a-half years.

The filing for was submitted by Merck & Co., Inc., Kenilworth, NJ, USA, it added.

The is a request for permission to introduce, or deliver for introduction, a biologic product into interstate commerce, as per the

Shares of Sun Pharma were trading 0.23 per cent higher at Rs 613.95 on BSE.

First Published: Wed, May 24 2017. 16:39 IST