1. Pink Sheet
  2. >>Geography
  3. >>Europe

Rare Disease Drug Govorestat & Odevixibat Resubmission Among New EU Filings

 
• By Neena Brizmohun

The latest marketing applications under review by the European Medicines Agency include govorestat for classic galactosemia, a condition for which there are no treatments, and odevixibat for Alagille syndrome.

EU marketing applications for a new batch of drugs are under review • Source: Shutterstock

Govorestat, Applied Therapeutics/Advanz Pharma’s investigational treatment for the rare genetic metabolic disease, classic galactosemia, is among the latest products that the European Medicines Agency has started reviewing for potential pan-EU marketing approval.

The central nervous system penetrant aldose reductase inhibitor, which was also recently filed in the US, targets a condition for which there are currently no

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 Europe

More from Geography

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.