Intercept Pharmaceuticals announced on Thursday that it would resubmit its application for nonalcoholic steatohepatitis (NASH) treatment to the U.S. Food and Drug Administration after the drug showed promise in an ongoing late-stage study.
In 2020, the agency declined to approve the drug, obeticholic acid, in 2020 stating that “predicted benefit remains uncertain and does not sufficiently outweigh the potential risks to support accelerated approval.”
According to doctors and experts, NASH is an advanced form of non-alcoholic fatty liver disease (NAFLD) which is usually caused by a build-up of fat in the liver.
Most of people who are suffering from NASH have no symptoms. Moreover, risk factors of NASH include obesity, gastric bypass surgery, high cholesterol and type 2 diabetes.
(With inputs from Reuters)