FDA Grants Fast-Track Label to Pfizer’s Combination Therapy for NASH

The FDA has handed Fast-Track designation to Pfizer’s investigational combination therapy ervogastat and clesacostat for the treatment of nonalcoholic steatohepatitis (NASH), a progressive form of nonalcoholic fatty liver disease.

The agency’s decision is based on study results showing that the ervogastat and clesacostat treatment combination led to a reduction of liver fat along with a favorable tolerability and safety profile.

The company said that ervogastat and clesacostat belong to groups of enzyme inhibitors that have demonstrated the ability to lower liver fat in patients with nonalcoholic fatty liver disease and could potentially lead to improvements in inflammation and fibrosis.

James Rusnak, Pfizer’s senior vice president and chief development officer for internal medicine and hospital, said that there are currently no FDA-approved therapies available for patients with NASH.