Iovance’s lifileucel for advanced melanoma and Madrigal’s resmetirom for nonalcoholic steatohepatitis are just a couple of the key decisions on the FDA’s docket this quarter.
Tag Archive for: nonalcoholic steatohepatitis
Akero Therapeutics said on Tuesday its lead drug missed the main goal in a mid-stage trial treatment of patients with a severe type of fatty liver disease, sending its shares tumbling 63% in premarket trading.
The company teased data for efinopegdutide, a GLP-1/glucagon receptor co-agonist, in nonalcoholic steatohepatitis compared to Novo Nordisk’s semaglutide, which is not yet approved for NASH.
The drug, efruxifermin, also met secondary efficacy goals when tested alongside a diabetes treatment belonging to a class of drugs known as GLP-1 receptor agonists in the trial.
The agency’s briefing documents highlighted increased risk of diabetes and liver injury from using the obeticholic acid oral tablets for treatment of nonalcoholic steatohepatitis.
The positive data sets the stage for the drug, resmetirom, to become the first approved treatment for NASH, or nonalcoholic steatohepatitis, a disease that affects about 5% of adults in the United States.
As a result of the industry’s steady progress in the clinic, coupled with the enormous commercial opportunity inherent in NASH, NASH stocks soared over the course of 2014 to 2018. Then, the bottom fell out.
Intercept Pharmaceuticals said it would resubmit its application for nonalcoholic steatohepatitis (NASH) treatment to the U.S. Food and Drug Administration based on new interim analysis of data from an ongoing late-stage study. The company is seeking approval for obeticholic acid to treat fibrosis or scarring associated with NASH, a serious progressive liver disease caused by excessive fat accumulation in the liver.