1. Scrip
  2. >>Therapy Areas
  3. >>Alimentary/Metabolic

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.

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

Lilly Scores With Orforglipron In Diabetes, Generating Excitement For Obesity

 
• By Alaric DeArment

The company announced positive topline results for the oral GLP-1 drug in type 2 diabetes that beat expectations.

Ironwood To Consider All Options With Apraglutide Setback In SBS

 
• By Joseph Haas

With the FDA asking for another Phase III trial, the short bowel syndrome drug apraglutide could be years away from market, while the Linzess patent expiry and near-term debt loom.

Pfizer’s Danuglipron Is Done, Sparking M&A Speculation

 
• By Jessica Merrill

The company discontinued development of its oral GLP-1 receptor agonist for weight management due to a safety signal.

Compounding Unlikely To Solve GLP-1 Affordable Access Issues

 
• By Alaric DeArment

The end of semaglutide and tirzepatide shortages means large-scale compounding is declining, ICER noted. But compounded versions – and the demand for them – are likely here to stay.

More from Therapy Areas

Seven Up For Sanofi and Regeneron With Dupixent CSU Approval

 
• By Kevin Grogan

The IL-4/IL-13 inhibitor has been approved in the US as the first targeted therapy in over a decade for chronic itching.

Lilly Scores With Orforglipron In Diabetes, Generating Excitement For Obesity

 
• By Alaric DeArment

The company announced positive topline results for the oral GLP-1 drug in type 2 diabetes that beat expectations.

In Brief: BriaCell’s Breast Cancer Cell Therapy Boosts Survival In Phase II

 
• By Sushmita Panda

BriaCell announced its cell therapy Bria-IMT plus checkpoint inhibitors bested Gilead’s Trodelvy in a Phase II trial in HR+ breast cancer; a Phase III trial is enrolling.