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Pfizer Granted FDA Fast Track Designation for Ervogastat/Clesacostat Combination for the Treatment of Non-Alcoholic Steatohepatitis (NASH)

Retrieved on: 
Thursday, May 26, 2022
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Receiving Fast Track designation from the FDA reinforces Pfizers belief in ervogastat/clesacostat as a potential treatment for NASH, a serious, progressive liver disease with no currently approved therapies, said James Rusnak, M.D., Ph.D., Senior Vice President and Chief Development Officer, Internal Medicine and Hospital, Pfizer.

Key Points: 
  • Receiving Fast Track designation from the FDA reinforces Pfizers belief in ervogastat/clesacostat as a potential treatment for NASH, a serious, progressive liver disease with no currently approved therapies, said James Rusnak, M.D., Ph.D., Senior Vice President and Chief Development Officer, Internal Medicine and Hospital, Pfizer.
  • The results of this study, which also includes arms investigating ervogastat as monotherapy, will inform a potential Phase 3 development program.
  • Diacylglycerol O-acyltransferase 2 (DGAT2) and acetyl-CoA carboxylase (ACC) are two key enzymes that regulate lipid metabolism.
  • At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives.