NON-ALCOHOLIC STEATOHEPATITIS (NASH)

Pursuing Breakthroughs in the Treatment of NASH

Non-alcoholic steatohepatitis (NASH) is a serious, progressive form of non-alcoholic fatty liver disease (NAFLD). NASH significantly increases morbidity, is associated with a higher risk of cardiovascular and cerebrovascular events (such as heart attack or stroke), and is a leading cause for liver transplants in the U.S.1,2 There are currently no therapeutic options approved for NASH, but Pfizer researchers are working to develop treatments for the disease and its complications to fill the existing significant unmet medical need.

For more information about our NASH pipeline and clinical trials, visit this page.

What is NASH?

Non-alcoholic steatohepatitis (NASH) is a serious, progressive liver disease caused by a buildup of fat in the liver and accompanied by inflammation, liver cell damage, and in some cases, scarring of the liver.3,4 Over time, NASH may progress to cirrhosis, liver cancer, liver failure, and even death.3

Who gets NASH and how?

Although NASH is largely unrecognized and underdiagnosed, it is believed to affect three to five percent of the adult global population, including an estimated 18 million adults in the U.S. alone.5,6,7 There are several factors that lead to NASH – some people are genetically predisposed to NASH, while others have contributing conditions. Patients who are obese, have metabolic syndrome, insulin resistance, type 2 diabetes, high levels of triglycerides or blood cholesterol, are more likely to be at risk for NASH.3

What are the symptoms of NASH?

Many people with NASH experience few or no symptoms until the disease is in an advanced stage.3 In some circumstances, people with NASH may experience fatigue, abdominal pain, and discomfort in the upper right side of the abdomen.3,8

How is NASH diagnosed?

Currently, the accepted standard for a definitive NASH diagnosis is liver biopsy, which can detect steatosis, liver inflammation, liver cell damage, and stages of fibrosis.9 Many physicians do not recommend this for all patients as biopsies are expensive, invasive, and carry a risk of serious complications.10,11,12 New non-invasive diagnostic tools and various types of imaging modalities are being investigated as alternative options to biopsy for screening and potentially diagnosing patients with NASH.

Can NASH be treated?

Once diagnosed, treatment options available to patients are currently very limited due to lack of FDA- or EMA-approved therapies (as of October 2020). Physical activity, weight loss and eating a healthy diet are recommended to manage or slow the progression of the disease.13 Therapeutic treatment candidates for the disease are in development.13

 

1 Organ Procurement and Transplantation Network Liver Transplant data, March 2019.
2 Haldar D, Kern B, Hodson J, et al. Outcomes of liver transplantation for non-alcoholic steatohepatitis: A European Liver Transplant Registry study. J Hepatol. 2019;71(2):313-322.
3 National Institute of Diabetes and Digestive and Kidney Diseases, Definition and Facts of NAFLD and NASH. Updated November 2016. Accessed June 2, 2020.
4 Perumpail B, et al. “Clinical epidemiology and disease burden of nonalcoholic fatty liver disease.” World journal of gastroenterology vol. 23,47 (2017): 8263-8276. doi:10.3748/wjg.v23.i47.8263.
5 Sherif ZA, Saeed A, Ghavimi S, et al. Global Epidemiology of Nonalcoholic Fatty Liver Disease and Perspectives on US Minority Populations. Dig Dis Sci. 2016;61(5):1214-1225.
6 NASH Definition & Prevalence. American Liver Foundation. https://liverfoundation.org/for-patients/about-the-liver/diseases-of-the-liver/nonalcoholic-steatohepatitis-information-center/nash-definition-prevalence/. Accessed January 7, 2020
7 Adapted model based on Estes C, Razavi H, Loomba R, Younossi Z, Sanyal A. Modeling NAFLD Disease Burden in China, France, Germany, Italy, Japan, Spain, United Kingdom, and United States for the period 2016-2030 Hepatology. 2018;67(1):123-133.
8 “NASH Symptoms.” American Liver Foundation. https://liverfoundation.org/for-patients/about-the-liver/diseases-of-the-liver/nonalcoholic-steatohepatitis-information-center/nash-symptoms/. Accessed May 19, 2020.
9 Nalbantoglu I and Brunt, E. “Role of liver biopsy in nonalcoholic fatty liver disease.” World journal of gastroenterology vol. 20,27 (2014):9026-9037. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4112884/
10 Thampanitchawong P, et al. Liver Biopsy: Complications and Risk Factors. World J Gastroenterol. 1999 Aug 15; 5(4): 301–304
11 Spengler E and Loomba R. Recommendations for Diagnosis, Referral for Liver Biopsy, and Treatment of NAFLD and NASH. Mayo Clin Proc. 2015 September; 90(9): 1233–1246.
12 Data on File – Source: Market Research.
13 Treatment for NAFLD & NASH. National Institute of Diabetes and Digestive and Kidney Diseases. https://www.niddk.nih.gov/health-information/liver-disease/nafld-nash/treatment. Accessed January 9, 2020.