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, and we do not necessarily view this pattern of variable causes as evidence the mortality signal is due to chance.”, as Reuters reported.
No good news for the Londoners, whose shares droped by 2% after FDA’ statement. However, AstraZeneca’ stock recovered after FDA’s advisory panel presented safety updates on the drug. The panel concluded that Onglyza’s cardiovascular risk was acceptable.
The advisory committee suggests that both, Onglyza and Nesina should be labeled, informing of the risk of heart failure, although the panel didn’t recommend any additional restriction on the drugs’ prescriptions.