NASH: Flying The Plane While Building It

Drug development for nonalcoholic steatohepatitis (NASH), a form of liver disease, is a game of incomplete information: pipeline evolution is occurring in parallel with continued efforts to better understand and manage the disease. To date, no therapy for patients with NASH has been approved and consequences of the condition can be severe, including cirrhosis and hepatocellular carcinoma.

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Up in the air: NASH field gains momentum but faces research challenges • Source: Shutterstock

Nonalcoholic fatty liver disease (NAFLD) is a silent epidemic of the western world, reported to affect a quarter of the US population. Prevalence of this condition has exploded in the last two decades and continues to grow worldwide, triggered by a surge in obesity and other related risk factors. Despite the high prevalence and recent interest in the space, NAFLD is still an emerging therapeutic area with incomplete scientific understanding and an evolving clinical care paradigm. Fortunately, the academic, medical and biopharma communities are actively engaged in addressing this emerging public health issue.

However, it is important to note that NAFLD represents a spectrum of disorders, encompassing a broad range of severities. The milder form of the disease, nonalcoholic fatty liver (NAFL), accounts for the majority of NAFLD patients, with a prevalence of around 65 million in the US. As the name suggests, nonalcoholic fatty liver is characterized by steatosis, or excessive fat in the liver

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