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FDA On Novo's Diabetes Combo: It's Complicated

 
• By Donna Young

A May 24 advisory panel meeting is critical for Novo Nordisk's effort to convince the FDA to approve the Danish company's fixed-dose combination diabetes drug IDegLira – which unites Victoza (liraglutide) with Tresiba (insulin degludec) – but regulators questioned the firm's trial design.

Some concerns raised by the FDA about a fuzzy trial design used by Novo Nordisk AS for a fixed-dose formulation that unites two of its already marketed drugs – Victoza (liraglutide), a glucagon-like peptide 1 (GLP-1) receptor agonist, and Tresiba (insulin degludec), a basal insulin – may throw a wrench into the firm's hope of turning the combo product into what the Danish company is hoping will be a big moneymaker.

The FDA wants its Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) to help the agency grapple with various issues with...

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