1. Pink Sheet

Vanda’s Tradipitant Gets CRL In Gastroparesis But Another NDA Filing Is Still On

 
• By Jessica Merrill

The company will file a new drug application with the US FDA by the end of the year for tradipitant in a different indication, motion sickness.

FDA rejected Vanda's NDA • Source: Shutterstock

Vanda Pharmaceuticals’s new drug application (NDA) for tradipitant for the treatment of symptoms in gastroparesis was rejected by the US Food and Drug Administration, but the company still intends to file tradipitant in a different indication – motion sickness – by the end of the year.

Key Takeaways
  • The FDA rejected Vanda’s NDA for tradipitant for the treatment of symptoms in gastroparesis due to concerns about safety and efficacy.

The company announced receipt of a complete response letter (CRL) for tradipitant in gastroparesis on 19 September. The CRL was...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Pink Sheet 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 Complete Response Letters

More from Product Reviews

How Will Regulatory Filing Winds Blow Globally For Elevidys Following Patient Deaths?

 
• By Francesca Bruce

Roche’s filing for Elevidys in the EU followed applications in Middle Eastern countries because those markets accept applications based on approval by the US Food and Drugs Administration.

New EU Approvals

 
• By Neena Brizmohun

The Pink Sheet's list of EU centralized approvals of new active substances has been updated to include two new products, one of which is Tepezza, Amgen's treatment for moderate to severe thyroid eye disease.

CAR-T REMS Removal Should Boost Access, But Long-Term Follow-Up, Black Box Remain

 
• By Sarah Karlin-Smith

The REMS removal and labeling changes should open up CAR-T treatment to many more US patients, although other regulatory hurdles and safety language that experts had wanted removed still stand.