Diabetes drugs of Takeda Pharmaceutical and AstraZeneca ($AZN) should be labeled at risk of heart failure associated with them, a group of U.S. FDA advisers recommended. Nearly all of the members of an advisory panel voted for the added safety information on labels.
At issue are Takeda's Nesina (alogliptin) and AZ's Onglyza (saxagliptin), both DPP-4 inhibitors for treating diabetes. The data indicated Takeda's drug was less risky, with only an insignificant risk of heart failure, while AZ's risk was considered statistically significant. Neither increased the risk of death due to stroke, heart attack or cardiovascular problems, the panel decided.
"Takeda is pleased with the recommendation of the Committee and we remain confident in alogliptin as an important treatment option for patients living with Type 2 diabetes," said Robert Jackson, vice president and global medical head, CVM-Respiratory Therapy, Takeda Pharmaceuticals International. "Today's outcome reinforces that the global EXAMINE trial met the FDA post marketing guidance requirements. The trial is important as it assesses cardiovascular safety in patients known to be at a high risk for cardiovascular disease."
AstraZeneca also said the FDA decision noted that the Saxagliptin Assessment of Vascular Outcomes Recorded in Patients with Diabetes Mellitus (SAVOR) study demonstrated that the use of saxagliptin in patients with Type 2 diabetes has an acceptable cardiovascular risk profile.
"AstraZeneca will also conduct further investigation to better understand the signal of hospitalization for heart failure found in the SAVOR results," the company said in a release.
The agency has been conducting special safety studies on diabetes drugs in general and for more than 6 years has required drugmakers to show their products did not increase cardiovascular risk.