Novartis’s Zolgensma Loses EU Accelerated Assessment

 
• By Alexandra Shimmings

Companies pleased at gaining an EU accelerated assessment for a product should be aware that the agency offers no guarantee that they will get to keep it. Novartis’s Zolgensma is one of seven drugs whose review the EMA has taken off the fast track.

Speed_Bump
Speed restrictions applied in Europe for Zolgensma • Source: Shutterstock

The EU review for Novartis AG/AveXis Inc.’s novel gene therapy Zolgensma is now going at a more sedate pace after the European Medicines Agency reverted its initial accelerated assessment to a standard review.

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 New Products

More from Scrip