Hepatology Patient Information
The prevalence of liver disease has increased significantly in recent years. According to the National Institute of Diabetes and Digestive and Kidney Diseases of the National Institutes of Health, it is estimated that 20 percent of Americans with Nonalcoholic Fatty Liver Disease (NAFLD) have Nonalcoholic Steatohepatitis (NASH). It is believed that 3 to 12 percent of adult Americans have NASH.1
NAFLD is an umbrella term for a spectrum of liver conditions that begin with a build-up of hepatic fat, which can set the stage for inflammation that may promote scarring known as fibrosis. Over time, fibrosis can progress to potentially fatal cirrhosis and even a form of liver cancer called hepatocellular carcinoma.
Usually, NAFLD and NASH are silent diseases with few or no symptoms. A patient may not show symptoms even if they develop cirrhosis due to NASH.
There is currently no approved treatment for NAFLD and NASH in North America and Europe.
Theratechnologies completed discussions with the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) regarding the proposed trial design and protocol for a Phase 3 clinical trial evaluating tesamorelin for the treatment of NASH. Currently evaluating opportunities to most effectively execute this program, including seeking a potential partner for late-stage development.