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

Depemokimab & Tzield Among 10 New EU Filings

 
• By Neena Brizmohun

GSK’s depemokimab, if approved, could become the first ultra-long-acting drug for treating asthma and chronic rhinosinusitis with nasal polyps. Meanwhile, Sanofi’s teplizumab, which the US approved as the first disease-modifying therapy for type 1 diabetes in 2022, has now been filed for review by the European Medicines Agency.

Business team analyzing income charts and graphs with modern laptop computer.
The EMA has started reviewing marketing applications for a new batch of drugs (Shutterstock)
Key Takeaways
  • The European Medicines Agency has added 10 new products to its list of drugs for which marketing authorization applications (MAAs) are currently under review.
  • The products are depemokimab, mavorixafor, nogapendekin alfa inbakicept, teplizumab, trofinetide, an influenza and COVID-19 vaccine, lutetium (177Lu) chloride, golimumab, aflibercept and ranibizumab.
  • All 10 products are being reviewed under the agency’s standard evaluation timeline, which usually takes around a year to complete.

The European Medicines Agency has begun reviewing for potential pan-EU marketing approval 10 new products, including depemokimab, GSK’s IL-5 inhibitor that could become the first ultra-long-acting drug for

Depemokimab, which is expected to be filed for review in the US in the first quarter, was recently

More from EU CHMP

New EU Filings

 
• By Neena Brizmohun

Brensocatib, Insmed's investigational treatment for non-cystic fibrosis bronchiectasis, is among the latest products that have been filed for review by the European Medicines Agency for potential EU marketing approval.

New EU Filings

 
• By Neena Brizmohun

Plozasiran, Arrowhead Pharmaceuticals' treatment for familial chylomicronemia syndrome, is among the latest products that have been filed for review by the European Medicines Agency for potential EU marketing approval.

PharmaMar Seeks EU Fast-Track Status For ‘Practice-Changing’ ES-SCLC Therapy

 
• By Neena Brizmohun

PharmaMar, which wants to use the Jazz Pharmaceuticals-partnered drug, lurbinectedin, in combination with Roche’s Tecentriq for treating extensive-stage small cell lung cancer, is one of two companies that this month sought an accelerated assessment of their planned EU marketing applications.

EU CHMP Opinions And MAA Updates

 
• By Neena Brizmohun

This is an update of recommendations from the European Medicines Agency's Committee for Medicinal Products for Human Use on the authorization of new medicines in the EU, and updates on EU marketing authorization changes recommended by the CHMP.

More from Approvals