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Stemline And Karyopharm Want More Time At EMA

The CHMP Stiil Has Issues Over Filings For Tagraxofusp And Selinexor

 
• By Maureen Kenny

A number of companies with marketing applications at the later stages of the EU review process are seeking extra time to address remaining concerns the European Medicines Agency’s drug evaluation committee, the CHMP, has about their filings.

Hourglass
Time matters for companies seeking new product approvals • Source: Shutterstock

Two of the products whose sponsors are seeking extra time to respond to concerns the European Medicines Agency has regarding their late-stage marketing authorization applications (MAAs) were originally being fast-tracked through the review system. 

Both products – Stemline Therapeutics’ tagraxofusp and selinexor from Karyopharm Therapeutics – have orphan status and have been...

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