FDA wants safety data before degludec approval.
In a statement released on Feb. 11, the manufacturer, Novo Nordisk, said that in a complete response letter, the FDA has requested "additional cardiovascular data from a dedicated cardiovascular outcomes trial" before the review of insulin degludec (IDeg) and insulin degludec combined with insulin aspart can be completed. The decision applies to both IDeg alone and IDeg combined with the fast-acting insulin analogue insulin aspart.
In September 2011, the company filed for approval of these products to improve glycemic control in adults with type 1 and type 2 diabetes.
"Novo Nordisk is evaluating the content of the complete response letter and will work closely with die FDA to provide the requested data," according to the statement, which adds that the company does not expect to have the data available in 2013. Approval is also dependent on the resolution of violations in current good manufacturing practice at manufacturing facility, outlined in a Dec. 12 warning letter from the FDA, the company said.
In November 2012, the FDAs Endocrinologic and Metabolic Drugs Advisory Committee unanimously recommended that Novo Nordisk conduct a cardiovascular outcomes study to investigate a cardiovascular safety signal detected in a men-analysis of clinical trials, an increase in a composite major cardiovascular event (MACE) endpoint of unstable angina pectoris, cardiovascular death, stroke, and acute coronary syndrome. But the panel was less united on whether the data should be required before or after approval, voting 8-4 to recommend approval.
Based on FDA guidance on cardiovascular risk assessments of new drugs for type 2 diabetes, preapproval safety analyses should provide reassuring estimates of risk.
Novo Nordisk, which markets insulin aspart as Novolog. If approved, the company plans to market insulin degludec as Tresiba and the combination product as Ryzodeg.
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|Publication:||Internal Medicine News|
|Date:||Mar 1, 2013|
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