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Novartis submits Exjade iron chelator

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Novartis submits its iron chelator Exjade (deferasirox, formerly ICL670) May 3 for treatment of chronic iron overload due to blood transfusions. The firm is touting the agent's once-daily dosing and oral route of administration as advantages over standard treatment, which requires a daily infusion that can take several hours. Novartis markets another iron chelating agent, Desferal (deferoxamine), which is administered via transfusion. The company reported during its Jan. 20 R&D update that Exjade missed its primary endpoint of non-inferiority to Desferal in a pivotal study, noting that the finding could impact timing or labeling (1Pharmaceutical Approvals Monthly February 2005, p. 3). The NDA was submitted within the firm's projected first-half 2005 timeframe...

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