The next global epidemic
As the levels of obesity around the globe continually grow, Non-alcoholic Steatohepatitis, or NASH, is rapidly becoming a serious health concern. NASH is estimated to affect 3 – 5% of the global population; well over two hundred million people worldwide1. Yet, despite its prevalence and severity, there are still no drug therapies approved for the treatment of NASH.
NASH is the progressive form of Non-Alcoholic Fatty Liver Disease or NAFLD - now the most common cause of liver disease in north America. Found in fatty livers, it causes inflammation that results in damage through scarring or fibrosis. In 20% of patients, this can develop into cirrhosis and eventually a loss of function.
A global epidemic
NASH is estimated to affect 16 million adults in the U.S. But experts suggest the figure could be as high as 39 million. In other developing countries, figures show a similar or higher incidence of the disease.
Although there is some variation in the susceptibility to the disease between different populations. In Japan, the prevalence of NASH is rising, despite the population not typically being overweight.
The potential for therapies? - A billion-dollar market
As end stage liver disease secondary to NASH is projected to become the most common indication for liver transplant by 2025, it is becoming ever more important to find new treatments strategies. This limited availability of drug treatment options, and the commercial potential of new therapies, has consequently spurred a frenzy of R&D activity.
Analysts estimate that the market could be worth between $20 billion to $40 billion within the next decade. In fact, analysts ResearchAndMarkets has recently put the figure even higher, at $61 billion by 2028, blaming the rising prevalence of NASH, increasing diabetic population, rising obesity, unmet medical needs and sedentary lifestyle.
Current management of NASH
Current initial management is focused on modifying lifestyle and reversing the conditions associated with NAFLD. Effective methods include weight reduction and exercise, combined with a reduction in alcohol consumption and a healthy diet. Bariatric surgery to reduce weight, such as gastric bypass, has also been shown to have an impact. In fact, a number of small studies have revealed that after surgical intervention, NASH resolved in between 55% and 100% of patients2.
As far as existing drugs are concerned, vitamin E, omega 3 fatty acids, statins and metformin, amongst others, have been investigated, with vitamin E showing some benefit.
But as lifestyle changes don’t work for everyone, and bariatric surgery is not always preferable, new drug therapies are sorely needed.
- Younossi ZM. Non-alcoholic fatty liver disease – A global public health perspective. Journal of Hepatology. 2019;70(3):531–544.
- Laursen TL, Hagemann CA, Wei C, Kazankov K, Thomsen KL, Knop FK, et al. Bariatric surgery in patients with non-alcoholic fatty liver disease - From pathophysiology to clinical effects. World Journal of Hepatology. 2019;11(2):138–249.
Related news and insights
Intercept Pharmaceuticals, Inc. announced an update on the timing of its pre-submission meeting with the FDA regarding the potential resubmission of its nonalcoholic steatohepatitis (NASH) New Drug Application (NDA) based on an interim analysis of the REGENERATE trial in patients with fibrosis due to NASH.