AstraZeneca, Bristol-Myers Squibb's Onglyza fails to show heart benefits in study

AstraZeneca and Bristol-Myers Squibb announced Wednesday that Onglyza (saxagliptin) failed to show superiority on a composite endpoint of cardiovascular death, non-fatal myocardial infarction or non-fatal ischaemic stroke in adults with type 2 diabetes when compared to placebo. For related analysis, read ViewPoints: AstraZeneca/Bristol-Myers Squibb SAVOR results – missed opportunity or sigh of relief?

The Phase IV SAVOR-TIMI-53 trial randomised 16 500 patients with type 2 diabetes who had a history of established cardiovascular disease or multiple risk factors to receive either Onglyza or placebo, both in addition to standard of care. The companies noted that top-line results showed that Onglyza met the primary safety objective of non-inferiority. AstraZeneca and Bristol-Myers Squibb added that the preliminary data are being analysed and the results will be submitted to the European Society of Cardiology for potential presentation in September.

Onglyza, which was initially approved in the US and Europe in 2009, generated sales of $709 million last year. Analysts at Berenberg Bank had suggested that positive results from the SAVOR-TIMI-53 study could have boosted demand for the DPP-4 inhibitor, with revenue reaching $3 billion by 2020.

Earlier this year, the FDA initiated a review of incretin-based diabetes drugs, including DPP-4 inhibitors and GLP-1 analogues, after unpublished study data suggested an increased risk of pancreatitis and pancreatic duct metaplasia in patients with type 2 diabetes treated with the therapies. For a related survey on doctors' views on the safety of incretin mimetic drugs, see Physician Views poll results: Endocrinologists increasingly less concerned about DPP-4/GLP-1 safety risk.

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