FDA Delays Decision on Novo Nordisk’s Diabetes Candidate IDegLira

September 12, 2016

The FDA has extended the review period for Novo Nordisk’s Type 2 diabetes candidate IDegLira, just weeks after the agency delayed its decision on a comparable therapy by Sanofi.

The FDA expects to decide whether to grant Novo Nordisk’s candidate an approval in December, the company said. Novo Nordisk does not disclose the reason for the delay, but it specified that the agency did not request additional data or trials.

The postponement positions Sanofi ahead of Novo Nordisk in the race to be the first to clinch the FDA’s approval for a fixed-dose and titratable Type 2 diabetes product in the U.S.

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