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FDA Committee to Review Heart Safety of New Insulin Product (Degludec)

Clinical trials suggest excess cardiovascular risk (Oct. 25)

The FDA has published information pertaining to an Advisory Committee meeting scheduled for November 8 to discuss the New Drug Applications (NDAs) for insulin degludec and insulin degludec/insulin aspart (Novo Nordisk). The proposed indication for these applications is the treatment of type 1 and type 2 diabetes mellitus.

According to the FDA document, the meeting will focus on the cardiovascular safety of degludec, as meta-analyses of several clinical trials have suggested an excess risk for cardiovascular events with this insulin over its comparators.

The meeting will also discuss any perceived benefits of the product to enable decisions to be made based on both benefit and risk analyses. With respect to benefit, several studies have suggested that degludec may be associated with a lower risk of hypoglycemia than the comparator insulin. Insulin is a requirement in type 1 diabetes and is necessary for continued adequate glycemic control in many type 2 diabetics. However, the risk of hypoglycemia may be a hurdle for effective titration of these therapies, the FDA says. Therefore, the possibility that insulin degludec and insulin degludec/aspart have a lower risk for hypoglycaemia will be an important consideration in the overall benefit-risk assessment of these products.

Insulin degludec is a once-daily basal insulin analogue with a long duration of action and slow absorption. The product has been studied in a large-scale clinical trial program (BEGIN), which examined its effect on glucose control and hypoglycemia, and the possibility that the dosing time may be adjusted to meet patients’ needs.

Insulin degludec/insulin aspart is a soluble combination of basal insulin degludec and a bolus boost of rapid-acting insulin aspart (NovoLog, Novo Nordisk).

The two insulin products were submitted for FDA review in September 2011.

Source: Novo Nordisk, October 25, 2012.

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