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Turalio: Why The EU Said No To The US-Approved Drug

The EU Rejected The Drug A Year After Its US Approval

 
• By Neena Brizmohun

Not everyone reviewing Daiichi Sankyo’s EU marketing application for Turalio agreed that the potential tenosynovial giant cell tumor treatment shouldn't be approved.

Drug Review Profile: Turalio
• Source: Alamy

Worries about unpredictable, potentially life-threatening effects of an orphan drug for treating a non-fatal condition. Missing data and uncertainty over the efficacy of the product even though it met its primary endpoint in a Phase III trial. A decision in the EU that contrasts sharply with the viewpoint in the US.

The statements all relate to Turalio (pexidartinib), Daiichi Sankyo’s drug for tenosynovial giant cell tumor (TGCT), and the European Medicines...

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