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gentlemen. This morning I along with the FDA statistician will be presenting the results

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of the MACE analyses performed. To give you an overview of what I will be discussing,

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I will briefly introduce Saxagliptin outlined as clinical development program and detail

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the common phase 2I study design. I will then go into subject demographics and

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disposition and subject exposure. I will then present the core of this talk the MACE

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analysis, which will include a presentation by the FDA statistician and a brief summary

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will conclude the presentation. As much of this information in the next few slides is

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already been presented this morning, I will be brief.

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FDA PRESENTATIONS

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NAOMI LOWY, M.D.

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Squibb is seeking an indication for Saxagliptin as an adjunct to diet and exercise to

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improve glycemic control in patients with type 2 Diabetes Mellitus. DPP-4 is the enzyme

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responsible for inactivation of GLP-1 and GIP, the incretin hormones, and in response to

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an enteral glucose challenge, the ingredients are gut hormones that regulate postprandial

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glucose excursion in a glucose dependent manner. Incretins regulate postprandial

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glucose excursion both by increasing Insulin secretion and decreasing glucagon release.

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This effect is glucose dependent, hypoglycemia is minimized. Januvia is currently the

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only FDA approved DPP-4 inhibitor.

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Good morning, Mr. Chairman, members of the Committee, Ladies and

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Saxagliptin is an oral Dipeptidyl peptidase-4 inhibitor and Bristol-Myers

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meeting is open for public observation, public attendees may not participate except

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with the specific request of the panel. Dr. Lowy is presenting.

Scribes, LLC Toll Free 1-800-675-8846 www.scribesllc.com

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The phase 2b3 program included in the NDA is comprised of eight

studies. Six are phase 2I studies in which the main study period was 24 weeks, a phase-

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