MediciNova, Inc., a biopharmaceutical company, announced that it has received Fast Track designation from the U.S. Food and Drug Administration for MN-001 (tipelukast) for the treatment of patients with nonalcoholic steatohepatitis (NASH) with fibrosis.
Fast Track is a process designed to facilitate the development and expedite the review of drugs that are intended to treat serious or life-threatening diseases.
Due to safety data from previous clinical studies of MN-001, the FDA said MediciNova may proceed with a Phase 2 study as the first clinical study of MN-001 in NASH.
NASH is a condition in which there is fat in the liver along with inflammation and damage to liver cells. It resembles alcoholic liver disease but occurs in people who drink little or no alcohol.