Last week, FDA expressed its concerns about AstraZeneca’s treatment for type 2 diabetes, Onglyza. According to Reuters, FDA found “significant or near significant” increase of death risk. However, the agency also admits that the cause of death is multifactorial and could not be directly related to AstraZeneca’s treatment.
The drug was developed as a result of AstraZeneca’s partnership with Bristol-Myers Squibb and it is included in a class of drugs known as DPP-4 inhibitors. As some panelists suggested, the suspect risk could be directly associated to DPP-4 inhibitors’ group. A group that also comprises Merk’s Januvia, whose trial results are expected to be released in June. However, Takeda’s DPP-4 inhibitor, Nesina was also reviewed by FDA’s staff, concluding that there was no statistically significant increase of mortal risk.
Onglyza’s preliminary review determined an increased risk of hospitalization and death from all causes. Despite the variable reasons of hospitalization, FDA said it “is not reassured that the observation that causes of death span multiple disparate etiologies,