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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.

fatty liver. plain black background
Novo Nordisk is targeting semaglutide at MASH (Shutterstock)
Key Takeaways
  • The European Medicines Agency has started reviewing the EU marketing authorization applications for 15 new drugs.
  • The products include semaglutide, for cirrhotic metabolic dysfunction-associated steatohepatitis, apitegromab, for spinal muscular atrophy, paltusotine, for treating acromegaly, remibrutinib, for chronic spontaneous urticaria, and plozasiran, for familial chylomicronemia syndrome.
  • Five of the 15 new drugs have been granted EU orphan drug status: copper (64Cu) oxodotreotide, apitegromab, paltusotine, tovorafenib and plozasiran.
  • Plozasiran is being reviewed under the EMA’s accelerated assessment pathway.

The European Medicines Agency has started reviewing for potential pan-EU marketing authorization 15 new drugs, including Novo Nordisk’s semaglutide for the treatment of non-cirrhotic metabolic

Semaglutide, a GLP-1 receptor agonist that is approved in the EU, the US and other countries for treating diabetes and obesity, was also expected to be filed for

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