USFDA accepts Biological License Application from Sun Pharma

Drug major Sun Pharmaceutical Industries Ltd on Wednesday said the US Food and Drug Administration (USFDA) has accepted its Biological License Application (BLA) for tildrakizumab.

In a statement issued here Sun Pharmaceuticals said the USFDA 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 and Co, Inc, Kenilworth, NJ, the US," the company said.

"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," Abhay Gandhi, CEO - North America Business, Sun Pharmaceuticals, was quoted as saying in the statement.

--IANS

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