As Analysis Did Not Reveal Causes Of The Increase In Death Incidents, FDA Asks Its Advisory Committee To Discuss This Safety Issue At April 2015 Meeting
UPDATE: "AstraZeneca, Takeda Diabetes Drugs Should Warn of Risk" (4/15/15, Bloomberg)
The AstraZeneca diabetes drugs Onglyza (saxagliptin) and Kombiglyze (saxagliptin plus metformin) will come under scrutiny at an April 14, 2015 FDA meeting according to early news reports about that upcoming event.
We previewed in this April 14, 2015 meeting of the FDA's Endocrinologic and Metabolic Drugs Advisory Committee in this article we wrote last month, "Cardiovascular Safety Issues For Onglyza And Kombiglyze Will Be Discussed At April 2015 FDA Advisory Committee Meeting".
Last Friday, April 10, FDA posted online their Briefing Material document for this Kombiglyze / Onglyza safety meeting (PDF file, 105 pages).
Strictly Confidential, No Obligation.
As regards what that FDA staff document contained and its significance, from an April 10, 2015 Bloomberg news report, "AstraZeneca’s Diabetes Drug May Raise Death Risk, FDA Says":
AstraZeneca Plc’s type 2 diabetes drug Onglyza showed an increased risk of death in an analysis by U.S. regulators of a clinical trial on the heart effects of the treatment. Food and Drug Administration staff said their analysis of deaths in the trial suggested patients using Onglyza experienced “significant or near-significant” increases in death from all causes, not just heart problems....
Since 2008, the FDA has asked manufacturers of drugs for type 2 diabetes to provide evidence the products don’t increase the risk of heart attack or other cardiovascular events.
Patients who use Onglyza also have a 27 percent increased risk of hospitalization for heart failure compared to those who were given a placebo, FDA staff said. The risk was first revealed in clinical trial results published in October 2013 in the New England Journal of Medicine ["Saxagliptin and Cardiovascular Outcomes in Patients with Type 2 Diabetes Mellitus"].
Onglyza didn’t increase or decrease the rate of heart attack, stroke or death, according to the [New England Journal of Medicine (NEJM)] article.
That October 2013 NEJM article led to a FDA Safety Announcement several months later, as we reported in this earlier article, "Possible Link Between Heart Failure And Onglyza Diabetes Type 2 Drug Is Being Investigated By FDA, As Announced In February 2014".
We will be watching for any significant developments coming out of this April 2015 FDA Advisory Committee Meeting concerning the safety of Onglyza and Kombiglyze such as a possible label change for these AstraZeneca diabetes drugs.