The Food and Drug Administration (FDA) last month rejected Intercept Pharmaceuticals’ nonalcoholic steatohepatitis (NASH) drug, creating a major delay in the drugmaker’s approval roadmap, BioPharma Dive reports.
According to the report, Intercept says the FDA decided the benefits of obeticholic acid (OCA) failed to outweight the potential risks.
The delay presents a new hurdle for Intercept as it works to develop the first marketed drug for NASH.
To read the full report on BioPharma Dive, click here.
