US FDA staff flag ‘serious’ safety risks for Intercept’s NASH treatment
May 17 (Reuters) – The U.S. health regulator’s staff reviewers on Wednesday raised various safety concerns from using Intercept Pharmaceuticals Inc’s (ICPT.O) treatment for a type of fatty liver disease, sending the drugmaker’s shares down 21% before the bell.
The U.S. Food and Drug Administration’s (FDA) briefing documents highlighted increased risk of diabetes and liver injury from using the obeticholic acid oral tablets for treatment of nonalcoholic steatohepatitis (NASH).
The staff asked the regulator’s panel of outside advisors, who meet on Friday, to consider whether the modest benefits from using the drugs for treatment of NASH outweigh the serious risks associated with it.
The panel’s meeting on Friday is the first advisory committee meeting for a drug to treat nonalcoholic steatohepatitis (NASH).
With no approved treatments for the disease yet, several drugmakers including Novo Nordisk (NOVOb.CO) and other smaller companies Madrigal Pharmaceuticals Inc (MDGL.O) and Akero Therapeutics Inc (AKRO.O) are racing to enter what is expected to be a multibillion dollar U.S. market.
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