1. Pink Sheet
  2. >>Product Reviews
  3. >>EU CHMP

EU Decision Time For Hemophilia Drug Concizumab & 10 Other Products

 
• By Neena Brizmohun

Concizumab sponsor Novo Nordisk and a number of other companies could soon learn whether or not the European Medicines Agency will give their respective drugs the marketing thumbs up.

Pills and question mark
Companies are waiting to hear whether the EMA will recommend approving their drugs (Shutterstock)

The European Medicines Agency is set to decide this week whether to recommend pan-EU marketing approval for a number of new products, including concizumab, Novo Nordisk’s drug for hemophilia A and B that was resubmitted for regulatory review in the US in June after being rejected there last year.

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 EU CHMP

Vertex’s Alyftrek For CF Among Six Orphans On Track For Pan-EU Approval

 
• By Eliza Slawther

The European Medicines Agency has recommended 16 drugs for EU-wide approval, including Vertex’s cystic fibrosis drug Alyftrek and five other orphans.

Semaglutide For MASH Among Raft Of New EU Filings

 
• By Neena Brizmohun

Novo Nordisk’s application seeking EU marketing approval to use its GLP-1 receptor agonist to treat cirrhotic metabolic dysfunction-associated steatohepatitis is one of 15 new drug filings the European Medicines Agency has started reviewing. Meanwhile, Arrowhead’s filing for its familial chylomicronemia syndrome, plozasiran, is being fast tracked.

SpringWorks To Make Its Case For Nirogacestat At High-Stakes EMA Meeting

 
• By Francesca Bruce

Nirogacestat was one of four products scheduled for an oral explanation meeting at the European Medicines Agency this week.

EMA To Consider Approvals For Eight Orphans, Including Vertex’s CF Drug Alyftrek

 
• By Francesca Bruce

The European Medicines Agency is this week expected issue opinions on whether the European Commission should grant EU marketing authorization for 19 new products.

More from Europe