Committee Votes to Change Labels for Onglyza and Nesina

By Rheingold Giuffra Ruffo & Plotkin LLP

A Food and Drug Administration advisory committee met Tuesday to discuss diabetes drugs made by AstraZeneca and Takeda Pharmaceutical. Although the Endocrinologic and Metabolic Drugs Advisory Committee found the drugs’ cardiovascular risk within acceptable limits, it suggested the FDA add data from trials on the heart effects to the labels of Onglyza and Nesina (made by AstraZeneca and Takeda respectively). The votes in favor of changing the labels of both drugs were casted by an overwhelming majority of the committee members.

The committee meeting was prompted by data showing both drugs increased the risk of hospitalization from heart failure and a clinical trial showing increased death rates among patients taking Onglyza. However, the committee was skeptical that Onglyza raised the risk of death since the study revealed no reason for the increase.

Other committee members voiced sureness that patients at risk could be identified, and that AstraZeneca could devise a plan to manage these patients. One committee member stated the cardiovascular risk for Onglyza is unacceptable. This committee member also voted to withdraw Onglyza from the market completely, finding the drug provides little benefit to consumers and too much risk.

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