FDA grants fast track designation to aramchol for NASH

The FDA has granted fast track designation to Galmed Pharmaceutical’s aramchol, a potential oral therapy to treat nonalcoholic steatohepatitis, according to a news release from the drugmaker.

Aramchol, a conjugate of cholic acid and arachidic acid, is indicated for patients with NASH who also are obese and have glucose intolerance, according to Galmed’s website.

“The fast track designation of aramchol will allow for continued contact between Galmed and the FDA to optimally design aramchol’s future studies, including clinical trials in the United States, and may enable Galmed to accelerate its development, FDA approval and the time to market,” Allen Baharaff, chief executive officer of Galmed, said in the release.

Galmed will initiate a phase 2b clinical trial of aramchol later this year, the release said, and will enroll 240 patients with NASH, as well as obesity and insulin resistance, from Israel, Europe and various Latin American countries. In a phase 2a clinical trial, aramchol effectively reduced liver fat when taken at 300 mg once daily for 3 months.

The FDA approved Galmed’s new drug application for aramchol in July.