FDA panel backs Novo's IDegLira

FDA's Endocrinologic and Metabolic Drugs Advisory Committee voted 16-0 on Tuesday that available data support approval of combination therapy IDegLira insulin degludec/liraglutide from Novo Nordisk A/S (CSE:NVO; NYSE:NVO) to treat adults with Type II diabetes. IDegLira is a fixed-ratio combination of long-acting insulin analog Tresiba insulin degludec and long-acting glucagon-like peptide-1 (GLP-1) analog Victoza liraglutide. Novo markets both components individually for Type II diabetes.

The committee shrugged off concerns raised by FDA reviewers in briefing documents about whether Novo had shown that IDegLira was superior to Tresiba alone (see BioCentury Extra, May 20). ...