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New Type 2 Diabetes Treatment Victoza Enters the Market

After months of anticipation, Victoza, Novo Nordisk’s once-daily GLP-1 analog (similar to Byetta), was approved on January 25, 2010, for sale in the US. FDA okayed the drug for both use as an add-on therapy to metformin, sulfonylureas (such as glimepiride), and thiazolidinediones (Actos and Avandia), as well as a single agent for those who aren’t able to tolerate sulfonylureas or metformin. The first of the “next generation” GLP-1 analogs (next-in-line exenatide once-weekly or EQW is up for approval later this month), Victoza has a promising profile in collectively speaking – in addition to lowering A1c about 1% on average, it prompts weight loss of 5-7 pounds (unlike the weight gain seen with sulfonylureas, thiazolidinediones, and insulin), isn’t associated with hypoglycemia, requires a very thin needle gauge, is dosed only once-a-day, and can be taken at any time of day. While studies show less nausea than for Byetta, still about 43% of patients taking the drug did experience some nausea - that said, you can see clever ways around this, such as Carol King's tip of taking it right before sleep to avoid the feeling.

However, while approval spells safe to use, the product will carry a “black-box” warning, FDA’s method for cautioning against potentially serious side effects – in Victoza’s case, medullary thyroid carcinoma, or MTC (a very rare cancer of specific cells within the thyroid gland called C-cells). While signals for MTC still have never been seen in humans, the drug will not be recommended in those with a personal or family history of MTC or multiple endocrine neoplasia syndrome type 2, a rare genetic disorder that predisposes individuals to MTC. Due to the warning, various post-approval studies will be required of Novo Nordisk, including a 15-year cancer registry, a long term risk-evaluation study, and further preclinical studies - this is in addition to a cardiovascular safety study. And that may be a good thing, as it means Victoza could have lots of supportive safety data in the long run. Overall, we found the FDA’s response very positive – in its approval, the agency stressed the importance of getting drugs on the market that reduced the long-term complications associated with diabetes, and we definitely see Victoza as a step in the right direction (leaders of the FDA said as much in a recent article in the prestigious New England Journal of Medicine). The drug is now available in 90% of US pharmacies nationwide – for one person’s experience with Victoza, see Test Drive in this issue of diaTribe, and if your current therapy isn't working for you, think about asking your healthcare provider about GLP-1. --LR

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