1. Scrip
  2. >>Therapy Areas

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.

RubberStampWarning_1200x675

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

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Scrip for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required
Start Free Trial

Already a subscriber?

More from Alimentary/Metabolic

More from Therapy Areas

Leo Roars To A Profit In Q1 As Adbry Grows In US

 
• By Kevin Grogan

The Danish firm's atopic dermatitis drug is holding its own despite strong competition from Sanofi/Regeneron’s Dupixent.

Multiple Launches Help Lilly’s Japan Growth

 
• By Ian Haydock

Lilly saw solid growth for its business in Japan last year on the back of several new launches and is building its obesity and Alzheimer's portfolios in the country.

Novo Nordisk Looks To Septerna For Oral Obesity Options

 
• By Mary Jo Laffler

Deal Snapshot: The Danish drugmaker is partnering with GPCR drug discovery expert Septerna to develop multiple small molecules for cardiometabolic targets.