Blow for Novo Nordisk, as FDA further delays Tresiba and Ryzodeg

Danish insulin giant Novo Nordisk (NOV: N) revealed late Sunday that, on February 8, it received a Complete Response Letter from the US Food and Drug Administration regarding the New Drug Applications for Tresiba (insulin degludec) and Ryzodeg (insulin degludec/insulin aspart), saying the FDA requires more data before it can consider approval of the company’s new type 2 diabetes products. Novo Nordisk’s shares slumped 15.5% to 905 Danish kroner in early trading this morning.

The decision was a surprise, given that an FDA advisory panel recently backed approval of the two long-acting insulin products, though recommending that a cardiovascular outcomes trial should be conducted (The Pharma Letter November 9, 2012). They have also been approved for marketing in Europe and Tresiba in Japan (TPLs January 22, 2013, and October 1, 2012).

Company unlikely to provide requested data during 2013