The cardiovascular safety profile of AstraZeneca’s diabetes drug Onglyza is acceptable, but its label should carry information about the potential increased risk of heart failure, US regulatory advisors have concluded.
In a decision that pleased AZ shareholders, the US Food and Drug Administration’s Endocrinologic and Metabolic Drugs Advisory Committee voted 13 to one (one abstained) that data from the SAVOR study show the use of Onglyza (saxagliptin) in type II diabetics has “an acceptable cardiovascular risk profile”.
Fourteen out of 15 Committee members recommended that the FDA supplement the products’ labelling to add new safety information on the higher risk of cardiovascular hospitalisation, while one voted to withdraw the drug from the market.
AstraZeneca said it will conduct further investigation to better understand the signal of hospitalisation for heart failure found in the SAVOR results. But analysts believe the FDA will likely take the view that this is a DPP-4 inhibitor class effect, which would be good news for Onglyza as the label changes would apply to its peers as well.
"Thus, even with information added to Onglyza's label for increased risk of heart failure hospitalisation, we do not expect the drug to be commercially disadvantaged versus other members of its class," Deutsche Bank analyst Richard Parkes reportedly said in a research note.
A review of outcomes data for Takeda's DPP-4 inhibitor Nesina (alogliptin) did not find a significantly increased risk of death, but all eyes will now be on Merck & Co's blockbuster Januvia (sitagliptin), long-term data for which is expected in June.