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Emmaus and Mitsubishi Tanabe Refuse To Take EU Approval Blows Quietly

 
• By Neena Brizmohun

Two companies explain why they believe the European Medicines Agency was wrong to say that they do not have sufficient study data to prove that their products should be approved for sale in the EU.

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The EMA says it needs more study data for Xyndari and Radicava • Source: Shutterstock

Emmaus Life Sciences and Mitsubishi Tanabe Pharma have both challenged the European Medicines Agency’s view that they do not have enough proof to show that their respective drugs for sickle cell disease and amyotrophic lateral sclerosis (ALS) are fit for sale in the EU.

The EMA said yesterday that it was recommending against the approval of Emmaus’s Xyndari (glutamine), and that Mitsubishi Tanabe had withdrawn the marketing authorization application (MAA) for its product, Radicava (edaravone)

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