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Jumping Before They Were Pushed – Kiadis And Aradigm Withdraw EU Filings

A Third Company, Actelion, Has Pulled An Indication Extension Request

 
• By Maureen Kenny

Notice of the withdrawal of pan-EU marketing authorizations applications by Kiadis Pharma and Aradigm are noted in the agenda of the latest meeting of the European Medicines Agency's key scientific committee, the CHMP. 

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The CHMP was planning to reject two applications • Source: Shutterstock

Two companies – Kiadis Pharma and Aradigm – have formally withdrawn pan-EU marketing authorization applications (MAAs) after they were told these were likely to be rejected. A third company, Actelion, has withdrawn an application to extend an indication of an already marketed product. 

The MAAs relate to Kiadis Pharma’s lead product and stem cell transplant adjunct, ATIR101, and Aradigm’s inhaled antibiotic,...

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