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Novo Nordisk Seeks IDegLira Approval

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Novo Nordisk (NVO - Free Report) recently submitted marketing applications to the European Medicines Agency (EMA) seeking approval for its type II diabetes candidate, IDegLira.

IDegLira is the combination product of insulin degludec, Tresiba and Victoza, the once-daily human GLP-1 analogue.

The application was based on data from the DUAL program, which consisted of two phase IIIa studies.

Patients treated with IDegLira achieved an average HbA1c reduction of 1.9% in both studies. HbA1c treatment target of 7% were achieved by 81% of the patients earlier treated with oral anti-diabetics and 60% of the patients previously treated with basal insulin.

The open-label DUAL I study, which enrolled 1,600 people, compared the efficacy and safety of IDegLira, Tresiba and Victoza in people with type II diabetes inadequately controlled with metformin with or without pioglitazone. DUAL I data was released in Aug 2012.

In Dec 2012, Novo Nordisk announced the completion of DUAL II, the second and final phase IIIa program for IDegLira. DUAL II demonstrated that patients can realize benefits from each of the components in the combination product and reconfirmed the competitive profiles of Tresiba and Victoza.

Novo Nordisk is working to make IDegLira available in a prefilled device.

Novo Nordisk has a strong presence in the diabetes care market. The company has one of the broadest diabetes portfolios in the industry. The Diabetes Care segment recorded growth of 15% in 2012 with sales coming in at DKK 60.9 billion. 2012 results were driven by strong revenues from NovoRapid, Levemir and Victoza. Victoza witnessed sales growth of 58% in 2012.

Novo Nordisk carries a Zacks Rank #3 (Hold). Currently, companies like Santarus, Inc. , Jazz Pharmaceuticals (JAZZ - Free Report) and Salix Pharmaceuticals Ltd. look well positioned with a Zacks Rank #1 (Strong Buy).

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