Nonalcoholic Steatohepatitis Agent Fast Tracked by FDA
Galmed Pharmaceuticals announced that the FDA has granted Fast Track designation to the investigational product, aramchol for the treatment of nonalcoholic steatohepatitis (NASH).
The company plans to initiate a Phase 2b clinical trial of aramchol in 240 NASH patients who also suffer from obesity and insulin resistance in countries outside of the U.S.
The FDA had cleared Galmed's Investigational New Drug (IND) application for aramchol in July 2014, which following completion of certain preliminary testing and protocol matters will permit Galmed to conduct clinical trials of aramchol in the U.S. for the treatment of fatty liver disorders. Currently there are no FDA approved drugs for the treatment of NASH.
For more information visit GalmedPharma.com.