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

Orphan Drugs Dominate Latest EU Filings

 
• By Neena Brizmohun

Sotatercept, marstacimab, elafibranor, eplontersen, mirvetuximab soravtansine, troriluzole and tiratricol are among the latest products that the European Medicines Agency has started reviewing for potential EU marketing approval.

A new batch of drugs are under review in the EU • Source: Shutterstock

Seven orphan drugs including MSD’s sotatercept, for pulmonary arterial hypertension (PAH), and Pfizer's marstacimab, for patients with hemophilia, are among the latest products that have been filed for review by the European Medicines Agency for potential pan-EU marketing authorization.

Sotatercept is an investigational activin signaling inhibitor that, if approved, “would be the first in its class, bringing a novel...

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

EMA Explores Supporting Drug Development For High Unmet Need Disorder Scleroderma

 
• By Neena Brizmohun

While treatments for scleroderma are in development, none are approved for the condition that is associated with high morbidity and mortality. The European Medicines Agency says guidance on how to design development programs for the disorder is needed.

EMA Nod For First MASH Drug Rezdiffra, Cell Therapy Zemcelpro And 11 Others

 
• By Eliza Slawther

Madrigal Pharmaceuticals’ Rezdiffra is on track to become the first medicine approved in the EU for non-cirrhotic metabolic dysfunction-associated steatohepatitis after the European Medicines Agency recommended that it be granted conditional marketing authorization.

BIO Notebook: Policy Uncertainty Constraining Dealmaking

 
• By Mandy Jackson and Joseph Haas

Highlights from Day Four of the BIO International Convention include policy concerns helping constrain dealmaking, Novartis discussing its approach to partnering, and Generate looking for funding to move into Phase III.