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.
Turalio: Why The EU Said No To The US-Approved Drug
The EU Rejected The Drug A Year After Its US Approval
Not everyone reviewing Daiichi Sankyo’s EU marketing application for Turalio agreed that the potential tenosynovial giant cell tumor treatment shouldn't be approved.
