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FDA Warning On Ocaliva Puts Intercept's NASH Opportunity In Jeopardy

 
• By Emily Hayes

FDA's warning about 19 deaths related to excessive, off-label dosing for Ocaliva in primary biliary cholangitis spurs fears doctors will curtail prescribing and, worse, that the larger upcoming NASH market opportunity may be affected.

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AnFDA warning about serious liver injury and 19 deaths related to excessive dosing of Intercept Pharmaceuticals Inc.'s Ocaliva in patients with primary biliary cholangitis, a rare liver disease, has raised fears about loss of sales in the short term and opportunity longer-term in the greater market opportunity of nonalcoholic steatohepatitis.

In a safety communication on Sept. 21, FDA warned that there was a problem with excessive dosing of PBC patients, resulting in an increased risk of serious liver injury and...

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