The U.S. Food and Drug Administration has granted Fast Track designation to Pfizer’s (NYSE:PFE) Ervogastat/Clesacostat Combination therapy for the treatment of Non-Alcoholic Steatohepatitis (NASH).
The Ervogastat/Clesacostat combination is being investigated in an ongoing Phase 2 clinical trial evaluating the impact of treatment on resolution of NASH or improvement in liver fibrosis.
The FDA's decision is supported by results of nonclinical studies and results of Phase 2a clinical study that showed that treatment with combination therapy reduced liver fat with a favorable safety and tolerability profile.
James Rusnak, M.D., Ph.D., Senior Vice President and Chief Development Officer, commented: “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.”
Fast Track Designation is intended to expedite the development and review of new drugs to treat serious medical conditions that fill unmet medical needs.
Price Check: Shares of Pfizer are trading higher at $53.95 in Thursday’s premarket session, according to Benzinga Pro.
