Eli Lilly’s Alzheimer’s Drug And Italfarmaco’s Duchenne Treatment Due For Oral Explanations At EMA

The sponsors of nine new medicines that are in the final stages of their review cycle in the EU were due or possibly due to appear before the European Medicines Agency to address outstanding concerns the agency has regarding the marketing applications of their products.

Sponsors of nine drugs are to make a case for their products before the EMA (Shutterstock)

Eli Lilly and Italfarmaco were due this week to appear before the European Medicines Agency’s human medicines committee, the CHMP, for oral explanations as to why their respective drugs, donanemab and givinostat, which are in the late stage of the regulatory review cycle, should be approved for marketing across the EU.

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

More from Europe

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

 

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

EMA’s Role In Regulatory Reliance For Post-Approval Changes

 
• By 

The European Medicines Agency’s assessments of applications for variations play a key role in supporting international regulatory reliance mechanisms. Companies can aid this by ensuring the scope of their post-approval changes is clear, and notifying the EMA when sharing reports with non-EU regulators.

Semaglutide For MASH Among Raft Of New EU Filings

 

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

 

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

More from Product Reviews

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

 

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

 

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.

Brazil’s ANVISA Clarifies Registration Procedures For Biologicals

 

Brazil’s drug regulator has published a new technical note updating guidelines on registration and post-registration procedures for biological products.