Intercept Wins FDA Approval for Drug to Treat Liver Disease

  • Ocaliva will be Intercept’s first product to reach the market
  • Company is also studying the drug in larger NASH market

Intercept Pharmaceuticals Inc. won approval for a drug to treat an uncommon, slow-progressing liver disease called primary biliary cirrhosis, its first product to reach the U.S. market.

The Food and Drug Administration cleared Intercept’s Ocaliva, also known as obeticholic acid, according to a statement from the company on Friday. The agency approved the drug with the condition that Intercept perform further studies to show it reduces patients’ risk of liver transplant and death. 

Primary biliary cirrhosis damages the ducts that carry bile, a digestive fluid, and can lead to a variety of serious complications, including liver cirrhosis and failure, according to the National Institutes of Health. The disease isn’t common, and mainly affects women between the ages of 30 and 60. 

The company is also studying the same drug for patients with another liver condition called nonalcoholic steatohepatitis, or NASH, which is associated with obesity and more common than primary biliary cirrhosis. The annual worldwide market for NASH treatments may be $5 billion to $10 billion, said Michael Yee, an analyst with RBC Capital Markets Corp., in a note earlier this month.

Obeticholic acid is projected to generate $1.6 billion in sales in 2020, according to analysts’ estimates compiled by Bloomberg.

To bring the drug to market faster, Intercept initially studied whether it lowers levels of alkaline phosphatase, or ALP, a marker of liver damage. The New York-based company is now enrolling patients in a study of the drug’s effect on rates of liver failure and death that it expects to complete in 2023, according to a summary posted by the National Institutes of Health.

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