FDA extends IDegLira review

Novo Nordisk A/S (CSE:NVO; NYSE:NVO) said FDA extended its review of Type II diabetes therapy IDegLira by three months, shifting its PDUFA date to December from September. Novo spokesperson Michael Bachner told BioCentury FDA has not requested additional data or trials, but declined to disclose details.

In May, an FDA advisory committee recommended approval of IDegLira, a fixed ratio combination of Tresiba insulin degludec and Victoza liraglutide. Novo markets both components individually to treat Type II diabetes. Tresiba is a long-acting insulin analog, and Victoza is a long-acting glucagon-like peptide-1 (GLP-1) analog (see BioCentury Extra, May 24). ...