Withdrawn application: Feraheme, ferumoxytol, Date of withdrawal: 09/03/2023, Initial authorisation
As results of the main studies showed that Feraheme was effective at treating iron deficiency anaemia due to different causes, the Agency considered that the proposed use of the medicine should cover all patients with iron deficiency anaemia, without differentiating between anaemia due to kidney disease and anaemia due to other causes.
In addition, the Agency raised a number of questions about uncertainties regarding the effectiveness and safety of Feraheme, to which the company would have needed to provide satisfactory answers before Feraheme could be authorised. At the time of the withdrawal, as the company had not yet responded to the questions, the Agency’s opinion was that the benefits of Feraheme did not outweigh its risks.
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