Novo Nordisk says US FDA advisory panel to focus on degludec cardiovascular safety

Denmark-based insulin giant Novo Nordisk (NOV: N) late yesterday announced that the US Food and Drug Administration has published information relating to the focus of the Advisory Committee meeting scheduled for November 8 to discuss the New Drug Applications for the company’s ultra-long acting insulin degludec and insulin degludec/insulin aspart.

Earlier this year, the FDA delayed the approval of the diabetes treatment products degludec and insulin degludec/insulin aspart (The Pharma Letter June 8). Tresiba (insulin degludec) and Ryzodeg (insulin degludec/insulin aspart) for the treatment of diabetes mellitus in adults were recommended for approval by the European Medicines Agency last week (TPL October 22), but the US decision is seen as pivotal, since this is where the biggest future sales are expected to be generated.

The FDA document noted that degludec, which Novo Nordisk plans to market under the brand name Tresiba, has been associated with lower risk of hypoglycemia, and said that factor "will be an important consideration in the overall benefit-risk assessment of this product."