Novo Nordisk submits liraglutide in U.S., Europe
This article was originally published in Pharmaceutical Approvals Monthly
Novo Nordisk submits once-daily analog of the glucagon-like peptide 1 analogue liraglutide for approval as monotherapy and add-on treatment of type 2 diabetes in U.S. and Europe May 23, riding a wave of strong data from the LEAD program. Approval is expected in first half of 2009. The NDA filing is supported by five randomized controlled Phase III trials evaluating over 6,500 people, of which 4,200 took liraglutide. Analysts predict initial surge in competition with Amylin's incretin mimetic Byetta, but liraglutide may suffer if once-weekly GLP-1 compounds reach the market. Novo Nordisk has a once-weekly type 2 diabetes drug in Phase I
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