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FDA's Dapagliflozin Review To Focus On Hepatic Effects, Cancer Risks

This article was originally published in The Pink Sheet Daily

Executive Summary

The agency will ask its Endocrinologic and Metabolic Drugs Advisory Committee to weigh these "unexpected" safety findings despite a clean cardiovascular profile for Bristol-Myers Squibb/AstraZeneca's first-in-class diabetes drug.

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Stringent Hepatic Monitoring Urged For Diabetes Drug Clinical Trials

Difficulties surrounding the assessment of a possible case of drug-induced liver injury in the dapagliflozin clinical program show why more standardized hepatic monitoring is needed in future studies of type 2 diabetes agents, one of FDA’s outside advisors said.

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