These Two New AstraZeneca Diabetes Medications With Saxagliptin Are Part Of The Incretin Mimetic Class Of Drugs
(Posted by Tom Lamb at DrugInjuryWatch.com)
At an April 14, 2015 meeting of the FDA's Endocrinologic and Metabolic Drugs Advisory Committee, results of the Saxagliptin Assessment of Vascular Outcomes Recorded in Patients with Diabetes Mellitus (SAVOR) trial for for AstraZeneca's relatively new diabetes drugs Onglyza (saxagliptin) and Kombiglyze XR (saxagliptin and metformin HCI extended-release) will be discussed.
For some background, one might want to read this article, "Possible Link Between Heart Failure And Onglyza Diabetes Type 2 Drug Is Being Investigated By FDA, As Announced In February 2014", which we posted about a year ago.
From a March 2015 statement issued by AstraZeneca in connection with this upcoming Kombiglyze XR / Onglyza FDA Advisory Committee Meeting:
The SAVOR (Saxagliptin Assessment of Vascular Outcomes Recorded in Patients with Diabetes Mellitus) clinical trial of Onglyza (saxagliptin) was a randomised, double-blind, controlled trial evaluating the effect of saxagliptin on the incidence of major adverse cardiovascular events in patients with type 2 diabetes mellitus and at an elevated risk for CV events. The SAVOR study was conducted as part of the Postmarketing Requirement for the US New Drug Application approval of Onglyza in accordance with the 2008 FDA guidance, “Diabetes Mellitus – Evaluating Cardiovascular Risk in New Antidiabetic Therapies to Treat Type 2 Diabetes.” The primary objective of this trial was to determine that the addition of saxagliptin to standard of care in this patient population did not significantly increase the incidence of major cardiovascular events as compared to placebo.
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And from the FDA announcement about this Endocrinologic and Metabolic Drugs Advisory Committee Meeting, as regards the Agenda:
During the morning session, the committee will discuss the results of the cardiovascular outcomes trial (CVOT), Saxagliptin Assessment of Vascular Outcomes Recorded in Patients with Diabetes Mellitus, for new drug application (NDA) 22350, Onglyza (saxagliptin) and NDA 200678, Kombiglyze XR (saxagliptin and metformin HCl extended-release) tablets manufactured/marketed by AstraZeneca AB.
Further, according to this FDA announcement the background material for that Advisory Committee Meeting should be available to the public no later than 2 business days before the meeting on the 2015 Meeting Materials, Endocrinologic and Metabolic Drugs Advisory Committee page at FDA’s website.
Besides saxagliptin (Onglyza, Kombiglyze XR), other diabetes drugs in the incretin mimetic class besides include exenatide (Byetta, Bydureon), liraglutide (Victoza), sitagliptin (Januvia, Janumet, Janumet XR, Juvisync), alogliptin (Nesina, Kazano, Oseni), and linagliptin (Tradjenta, Jentadueto).
We will watch for further developments surrounding the safety profile of Onglyza and Kombiglyze XR as well as these other incretin mimetic diabetes drugs.