2009: Year in Review (Continued)

  • Byetta approved for stand-alone use: Byetta, which had formerly been approved only as an add-on therapy for people whose glycemic goals were not met with other medications, was approved for use on its own this year – approved for monotherapy, in medical parlance. This helps doctors who want to prescribe it for people early in disease therapy – though this hasn't been proven yet, many believe Byetta will ultimately be shown to protect the heart. This also paves the way for a similar indication with Exenatide Once Weekly, a long-acting formulation of the injectable medication Byetta; it is a once-weekly injection for people with type 2 diabetes, and is in line for FDA approval in 2010.

  • Liraglutide approved in Europe: Liraglutide, a GLP-1 agonist, was approved in Europe this year but was delayed in the U.S. Liraglutide is in the same drug class as Byetta but only needs to be injected once per day instead of twice a day like Byetta. In a study by Novo Nordisk, the company that makes liraglutide, the drug also showed better glycemic control compared to Byetta (drop in A1C of 1.12% versus 0.79% with Byetta), as well as superior drops in fasting plasma glucose, though not in post-prandial (after meal) measures.

  • Liraglutide FDA advisory panel surprise: Since it was the second GLP-1 agonist (after Byetta) to be submitted to the FDA for approval, we expected that liraglutide's approval process would be fairly straightforward. But out of the blue, concerns over a particular type of thyroid cancer (called C-cell carcinoma) took center stage. In rat and mouse models treated with liraglutide, elevated hormone levels indicative of the cancer and excessive thyroid cell growth were observed. The FDA advisory panel voted nearly unanimously that these C-cell findings were relevant to human beings. The committee was split evenly (with one abstention) on whether the C-cell carcinoma data should permit marketing of the drug. The controversy set off a very public sparring match between Novo Nordisk, the company that developed liraglutide, and Amylin/Eli Lilly, the developers of Byetta. Novo Nordisk claimed that C-cell carcinoma was an effect of all GLP-1 agonists, while Amylin and Eli Lilly claimed that their product was not subject to the effect. It should be noted that C-cell carcinomas are very common (occurring in 3-5% of autopsies in North America) and usually harmless (we note that papillary cancer was voted not a concern at the meeting). Our company, Close Concerns, did extensive research on the issue, speaking to a range of experts who emphasized that medullary carcinoma really isn't a thyroid cancer, that it is a cancer of the C-cells, not of the thyroid tissue per se. Their understanding seems to be that rodent C-cells express a lot of GLP-1 receptors, while human C-cells (cell lines, that is) do not. Thus, many believe this is a rodent-specific issue, not relevant to humans. The question is how to prove that to the FDA. While, as always, we believe that safety trumps all other issues, we also believe that better treatments are needed and that poor diabetes management has become a major public health problem in the U.S. that affects everyone – patients and taxpayers (who pay for out-of-control complications that stem from poor management) alike. It will be very interesting to see how this moves forward – at press time, Novo Nordisk had said that it would provide another update by February 6, 2010 – it had earlier expressed hope that the FDA would approve liraglutide by year-end.

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Last Modified Date: April 23, 2013

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