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Novo awaits green light for diabetes drug

Nature Biotechnology volume 27, pages 682–684 (2009)Cite this article

An Erratum to this article was published on 01 October 2009

This article has been updated

As Nature Biotechnology went to press, Novo Nordisk awaited a decision from the US Food and Drug Administration (FDA) on its weekly, anti-diabetic drug Victoza (liraglutide). After the European Commission's approval of Victoza in July, the Bagsvaerd, Denmark–based giant biotech is upbeat about its drug's prospects. Standing in the path of Victoza's FDA approval, however, are preclinical findings, originally discussed during an FDA Endocrinologic and Metabolic Drugs Advisory Committee in April, that suggest C-cell thyroid cancer could be a potential safety concern associated with the drug. And even though clinicians are optimistic about the company's ability to address these tumorigenicity concerns, Victoza faces several hurdles before commercial success: a diabetes market already crowded with small-molecule drugs, a long-acting form of Byetta (exenatide; synthetic exendin-4) that could be launched as soon as next year and uncertainty as to whether the FDA will follow the positive opinion of its European regulatory counterpart.

The Danish company is banking on Victoza's approval to secure a significant tranche of the multibillion-dollar type 2 diabetes market currently tapped by Byetta, Amylin Pharmaceuticals/Eli Lilly's first-in-class synthetic molecule originally isolated from the salivary venom of Gila lizard, which mimics the activity of human glucagon-like peptide-1 (GLP-1) and was originally approved in 2005. “The type 2 diabetes market occupied around $15 billion in 2008,” says Sylvia Miriyam Findlay, program leader for Frost & Sullivan's pharmaceuticals and biotech in London. “By 2013, it is likely to reach $22 billion.” Novo believes that Victoza has an edge over Byetta owing to its improved pharmacokinetic/pharmacodynamic profile: Victoza is injected weekly, whereas Byetta must be administered twice daily.

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Figure 1: The role of DPP-4, GLP-1, GIP in glucose homeostasis.

Change history

  • 08 October 2009

    In the version of this article initially published, GLP-1 was incorrectly described as “glucose-lowering peptide-1”; the correct definition is “glucagon-like peptide-1.” The article also stated incorrectly that Amylin and Lilly “filed a new drug application for this drug in July…” referring to Exenatide Once Weekly. This should be corrected to “heir new drug application was accepted for review by the FDA in July.…” The error has been corrected in the HTML and PDF versions of the article.

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    Mike May

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May, M. Novo awaits green light for diabetes drug. Nat Biotechnol 27, 682–684 (2009). https://doi.org/10.1038/nbt0809-682c

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