AstraZeneca diabetes drug could ‘significantly’ increase mortality
pharmafile | April 13, 2015 | News story | Research and Development, Sales and Marketing | AstraZeneca, FDA, Nesina, Onglyza, Takeda, alogliptin, cardiovascular, saxagliptin
AstraZeneca’s diabetes drug Onglyza may lead to a ‘significant increase’ in risk of death according to a new analysis from the FDA.
The US regulator looked at findings from AZ’s large SAVOR trial, which tested Onglyza (saxagliptin) – a dipeptidyl-peptidase-4 (DPP-4) inhibitor – in patients with type 2 diabetes with established cardiovascular disease or at high risk of heart problems.
A 27% increase in hospitalisation due heart failure was reported in patients treated with the drug. The FDA says that this is a public health concern as a ‘substantial’ number of patients, regardless of treatment assignment, had recurrent events or died during the trial.
Further analysis by the regulator also suggested that there were ‘significant or near-significant’ increases in all-cause mortality in patients taking the medicine, although the report added that “exploratory analyses to elucidate the etiology behind the all-cause mortality signal were unrevealing and did not shed light on a mechanism beyond treatment differences”.
The report was published ahead of an advisory committee review due to be held on Tuesday, which could lead to a label change for Onglyza.
The safety of diabetes drugs has been an area of increasing concern for the FDA, and in 2008 the regulator issued guidance requiring pharma firms to conduct trials to show that new treatments do not come with an increased risk of heart failure.
Another study initiated because of these guidelines looked at Takeda’s Nesina (alogliptin), also a DPP-4 inhibitor, but recent analysis of the results by the FDA found no significant increase in the risk of hospitalisation due to heart failure for those taking the treatment.
The regulator is awaiting results from a similar large trial of Merck’s leading DPP-4 inhibitor Januvia (sitagliptin), which could show whether it is the drug class itself that is the root cause of these concerns.
Onglyza was recently approved by the Scottish Medicines Consortium (SMC), becoming the first DPP-4 inhibitor approved for use in combination with insulin in the country.
At the time, Lisa Anson, president of AstraZeneca UK and Ireland, said: “Saxagliptin has one of the most robust data sets in type 2 diabetes, demonstrating clinically meaningful efficacy while also providing extensive insight into health outcomes beyond HbA1c.
“Together with the latest advice from the SMC, we hope that these data help clinicians feel confident in using saxagliptin in a broad range of patients, including those with renal impairment and other complications.”
George Underwood
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