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Intercept's NASH treatment faces safety concerns and plunging shares.

1 min read
Source: Reuters
Intercept's NASH treatment faces safety concerns and plunging shares.
Photo: Reuters
TL;DR

The US FDA staff has raised concerns about the safety risks of Intercept Pharmaceuticals' treatment for nonalcoholic steatohepatitis (NASH), called obeticholic acid (OCA), citing increased risk of diabetes and liver injury. The FDA's outside advisers are set to discuss the drug on Friday. The drug was expected to become the first approved NASH therapy, but the FDA rejected the company's marketing application in 2020 due to potential risks. The total patient population eligible for OCA, if approved, will be between 6 million and 8 million Americans.

Topics:businesshealthcare#drug-safety#fda#healthcare#intercept-pharmaceuticals#liver-disease#nash
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  1. US FDA staff flag 'serious' safety risks for Intercept's NASH treatment  Reuters
  2. Intercept's latest NASH bid in jeopardy after FDA questions drug's efficacy, safety  FiercePharma
  3. Why Intercept Pharmaceuticals Shares Are Plunging Today  Yahoo Finance
  4. Intercept Shares Fall as FDA Again Questions Risk-Benefit of NASH Treatment  BioSpace
  5. Intercept's (ICPT) Liver Drug Combo Gets FDA's Orphan Drug Tag  Yahoo Finance

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