FDA panel recommends warnings for certain diabetes drugs

A US Food and Drug Administration panel has voted to recommend that labels for UK pharma major AstraZeneca’s (LSE: AZN) diabetes drug Onglyza (saxagliptin) and Kombiglyze (saxagliptin/metformin) include a warning regarding a potential risk of heart failure and death.

Last week staffers raised concerns about Onglyza in its briefing documents ahead of the review by the Endocrinologic and Metabolic Drugs Advisory Committee meeting yesterday. The FDA panel noted that patients when treated with Onglyza experienced a 27% increase in the risk of hospitalization due to heart failure as compared to placebo, and patients demonstrated a significant or near-significant increase in the risk of death from all causes. These results were observed from the SAVOR study, conducted in type 2 diabetes patients with established CV disease or at a high risk of CV disease.

The panel also agreed that similar warnings should be added to diabetes drug Nesina (alogliptin), from Japan’s largest drugmaker Takeda Pharmaceutical (TYO: 4502). The panel voted that both drugs carried an acceptable heart safety profile.