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FDA Grants Fast Track Designation To Pfizer's Ervogastat Combination For Liver Disease Treatment

The U.S. Food and Drug Administration has granted Fast Track designation to Pfizer Inc.'s (PFE) investigational combination therapy for the treatment of non-alcoholic steatohepatitis or NASH with liver fibrosis: ervogastat and clesacostat.

Fast Track is a process designed to facilitate the development and expedite the review of new drugs and vaccines intended to treat or prevent serious conditions and address unmet medical need.

"Receiving Fast Track designation from the FDA reinforces Pfizer's belief in ervogastat/clesacostat as a potential treatment for NASH, a serious, progressive liver disease with no currently approved therapies," said James Rusnak, Senior Vice President and Chief Development Officer, Internal Medicine and Hospital, Pfizer.

Pfizer noted that it is currently studying ervogastat/clesacostat in an ongoing Phase 2 clinical trial evaluating the impact of treatment on resolution of NASH or improvement in liver fibrosis (NCT04321031), expected to complete in 2024.

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