In Brief: Novo Nordisk A/S
Wednesday, November 19 2008 | Comments
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The Food and Drug Administration rescheduled its advisory committee meeting to review the New Drug Application (NDA) for Novo Nordisk A/S' liraglutide type 2 diabetes therapy from March 2 to April 2 or 3. The company said that there is no change expected in the review timeline. Liraglutide is a human glucagon-like peptide-1 that stimulates the release of insulin only when glucose levels are too high and also stems appetite. The NDA was supported by data from the LEAD program of five double-blind, randomized trials that included approximately 6,500 patients, of which nearly 4,200 received liraglutide. Liraglutide provided a statistically significant benefit on the primary endpoint of lowering hemoglobin A1C and on the secondary endpoint of weight loss in these trials. Print |
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