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One In, One Out: Mirum Seeks New EU Indication For Maralixibat, Withdraws Another

Kyowa Kirin And Sanofi Want CHMP To Re-Examine Earlier Opinion About Their Products

 
• By Vibha Sharma

Sponsors of three drugs have withdrawn their EU marketing authorization applications in the middle of the assessment process, including one for a bladder cancer therapy that was recently turned down in the US.

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Companies Can Withdraw Their Marketing Applications At Any Stage Of The EMA Review • Source: Alamy

Mirum Pharmaceuticals has withdrawn the EU marketing authorization application (MAA) for its orphan drug maralixibat, which was being reviewed by the European Medicines Agency for treating progressive familial intrahepatic cholestasis type 2 (PFIC2).

It is one of three EU MAAs that have been withdrawn mid-review by sponsors, it was revealed in the

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