 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.
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.
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 and if your current therapy isn't working for you, think about asking your healthcare provider about GLP-1. |
