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PharmaMar’s Aplidin Back On EMA’s Agenda After Conflict Of Interest Controversy

 
• By Neena Brizmohun

The European Medicines Agency is re-evaluating the marketing application for Aplidin. The initial application was rejected in 2018, but that rejection was revoked last year following a court case for another company’s drug that clarified impartiality requirements for experts consulted by the EMA.

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The EMA is re-evaluating the marketing application for Aplidin (Shutterstock)
Key Takeaways

The European Medicines Agency is re-evaluating the EU marketing authorization application (MAA) for Aplidin (plitidepsin), PharmaMar’s treatment for multiple myeloma.

The initial MAA was rejected in 2018 but the European Commission revoked the rejection last year, after a Court of Justice of the EU ruling last March clarified impartiality requirements for experts consulted by the EMA.

PharmaMar had for a long time maintained there had been a conflict of interest in the EMA’s review of Aplidin.

A lawsuit it filed in 2018 was closed last November, and the commission was ordered to bear its own costs and to pay those of PharmaMar.  

There is expected to be activity at the European Medicines Agency this week regarding the re-evaluation of PharmaMar’s EU marketing application for Aplidin (plitidepsin), which was rejected in 2018 in...

According to the draft agenda of the latest monthly meeting of the EMA’s human medicines committee, the CHMP, rapporteurs who will re-examine the marketing authorization...

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