May 26, 2022
FDA granted fast track designation for ervogastat/clesacostat for the treatment of NASH
Pizer announced that the U.S. Food and Drug Administration (FDA) granted fast-track designation to Pfizer’s investigational combination therapy, ervogastat/clesacostat, for treating patients with non-alcoholic steatohepatitis (NASH) with liver fibrosis.
The fast track designation was provided based on the Phase 2a clinical study, in which ervogastat/clesacostat reduced the liver fat and showed a favourable safety profile.
Fastrack designation is given to those drugs which address the patients with high unmet needs and are indicated to treat or prevent serious diseases.