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AstraZeneca Exanta "not approvable"

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

AstraZeneca's anticoagulant Exanta (ximelagatran) is "not approvable," the company announces Oct. 8. The agency's decision, reached two weeks ahead of the Oct. 23 user fee date, is in line with the Cardiovascular & Renal Drugs Advisory Committee's Sept. 10 recommendation against approval for all three indications being sought. Liver safety has been a key safety concern with Exanta; AstraZeneca previously indicated that labeling would likely include requirements for regular liver function monitoring (1Pharmaceutical Approvals Monthly Jan. 1, 2004, p. 17). During an Oct. 6 conference call, VP Hamish Cameron described the situation as "a clash between what might be termed regulatory medicine and clinical medicine"...

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