UPDATE: Novo Nordisk rises as it says it plans to resubmit Tresiba and Ryzodeg NDAs in USA

Danish diabetes care giant Novo Nordisk (NOV: N) has decided to submit the pre-specified interim analysis of DEVOTE as part of a Class II Resubmission of the New Drug Applications of Tresiba (insulin degludec) and Ryzodeg (insulin degludec/insulin aspart) to the US Food and Drug Administration.

The resubmission is expected to take place within the next month, said Novo Nordisk, whose share price rose 11.6% to 373.80 Danish kroner shortly after markets opened this morning. The stock is up almost 50% over the past year.

Nearly two years ago, Novo Nordisk suffered a second setback with regard to FDA review of the two ultra long-acting insulin products, when the agency said it requires more data before it can consider approval of Tresiba and Ryzodeg (The Pharma Letter February11, 2013). Specifically, it requested additional cardiovascular data from a dedicated cardiovascular outcomes trial because of worries the drugs might be linked to higher rates of heart attacks or strokes. That decision was a surprise, given that an FDA advisory panel recently backed approval of the products, though recommending that a cardiovascular outcomes trial should be conducted.

Pharma industry analysts forecast Tresiba will generate annual sales of $2.2 billion by 2020, according to consensus estimates compiled by Thomson Reuters Cortellis. Ryzodeg has been approved in Aruba, Brazil, Chile, Costa Rica, El Salvador, the European Union, Hong Kong, Iceland, India, Israel, Japan, Kazakhstan, Macedonia, Mexico, Norway, Russia, South Korea and Switzerland. Tresiba has regulatory approval in Argentina, Aruba, Bangladesh, Bosnia & Herzegovina, Brazil, Chile, Colombia, Costa Rica, El Salvador, the EU, Honduras, Hong Kong, Iceland, Israel, India, Japan, Kazakhstan, Lichtenstein, Lebanon, Macedonia, Mexico, Nepal, Norway, South Korea, Switzerland and Russia.