Intercept drug gets FDA rejection for NASH
Obeticholic acid was for treatment of fibrosis due to nonalcoholic fatty liver disease.June 20, 2020
Manufacturer: Intercept Pharmaceuticals
Condition: Nonalcoholic steatohepatitis (NASH)
Patients with NASH, a form of fatty liver disease, may have no visible symptoms for years. When liver damage from NASH has led to scarring and hardening of the liver (cirrhosis), then the patient may feel severe tiredness, weakness, weight loss, yellowing of the skin or eyes, spiderlike blood vessels on the skin, or long-lasting itching.
Health care providers don’t know the exact cause. Obesity may be a factor.
Sometimes, nonalcoholic fatty liver disease (NAFLD) can develop into the aggressive form of fatty liver disease called NASH. About 20 percent of people in the United States have NAFLD. Of those, about 20 percent have NASH (5 percent of people in the U.S. or 15 million adults). The main characteristic of NAFLD is too much fat in the liver. NASH is associated with both fat and inflammation in the liver, which leads to liver fibrosis and may progress to cirrhosis, liver failure and liver cancer.1
There are no FDA-approved pharmacological treatments for NASH. Lifestyle modifications are recommended, including diet, weight loss and exercise.
Prime monitors the drug pipeline
The drug pipeline is full of new, groundbreaking specialty drugs that may help members live better and feel well. More NASH drugs are being developed by multiple manufacturers. Combination therapy is possible that may further increase the cost of treatment.
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