1. Pink Sheet
  2. >>Product Reviews

New Trial With Longer Liver Elevation Needed For Iclaprim, US FDA Tells Motif Bio

 
• By Bridget Silverman

Longer follow-up is part of regulatory path forward, the struggling antibiotics firm says after meeting with US FDA to discuss complete response letter.

Conceptual image of liver damage as a result of drugs, viruses, toxins, bacteria, parasites, 3D illustration - Illustration
Evaluating potential liver damage in an additional clinical trial would be needed for approval of Motif Bio's antibiotic iclaprim, which received a complete response letter in February. The path forward become clearer after the firm met with US regulators last month.

The US Food and Drug Administration wants to see another clinical trial of Motif Bio PLC’s antibiotic iclaprim with a longer follow-up period to assess the potential for latent liver toxicity, the company indicated to analysts on a call about the regulatory path forward after a February 2019 complete response letter.

Motif Bio execs met with the FDA on 3 May to discuss the complete response letter (CRL) announced 14 February 2019 for iclaprim’s new drug application for IV treatment of acute bacterial skin and skin structure infections (ABSSSI)

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 Product Reviews

More from Pink Sheet

Recent and Upcoming FDA Advisory Committee Meetings

 
• By Sue Sutter

Recent and upcoming US FDA advisory committee meetings and a summary of the topics covered.

UK Health Data Research Service Looks ‘Encouraging’ For Industry, But Implementation Details Will Be Key

 
• By Anabel Costa-Ferreira

Marcus Vass and Vladimir Murovec of international law firm Osborne Clarke tell the Pink Sheet what the government's planned HDRS might mean for industry, and how it compares with the European Health Data Space.

EU Health Data Space May Speed Up R&D Through Access To Multi-Omics & Clinical Record Data

 
• By Eliza Slawther

The European Health Data Space framework will allow companies to accelerate R&D processes and identify new molecular targets faster by facilitating centralized access to certain types of high-quality data, Finland’s Orion Pharma says.