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Thank you, Roland. While the cardiovascular safety profile of treatments

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for type 2 diabetes has always been of interest, the regulatory environment for this topic

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3 program. There was low risk for hypoglycemia. As described in the briefing book, we

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observed no adverse effects with respect to lipid parameters, blood pressure, or heart rate.

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Saxagliptin was associated with no or minimal differences in weight change compared

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with control. In addition, we identified no hepatic, pancreatic, skeletal, myopathy, or

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renal safety signals and there was no evidence for clinically meaningful or consequential

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effects on laboratory parameters.

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collaborated with the FDA to generate the data needed to assess the cardiovascular safety

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profile for Saxagliptin. The FDA has outlined key design features for clinical

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development programs to ensure adequate assessment of CV safety. The details are

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discussed in the Agency’s guidance document in our briefing book. The FDAs criteria

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for assessing CV safety of new therapies are summarized in the next slide.

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Overall, Saxagliptin was well tolerated at all doses studied in the phase

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CARDIOVASCULAR SAFETY PHARMACOVIGILENCE PLAN

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BENEFIT-RISK

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ROBERT WOLF, M.D., F.A.C.C.

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of treatments for type 2 diabetes would indicate that the upper band for the confidence

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interval should be less than 1.8 in order for the product to be approvable. As described in

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evolved prior to and after we filed the NDA for Saxagliptin.

This slide summarizes how we adapted to this changing environment and

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As Dr. Joffe described, the FDA specified criterion to assess approvability

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With this, I would like to introduce Dr. Wolf, who will review the

Saxagliptin cardiovascular safety profile. Thank you.

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