The Devil is in the details

The Devil is in the details

The closer Diabetic Investor examines the Victoza® approval the more questions we have. First and foremost, is the fact the Victoza® will carry a black box warning regarding the risk of thyroid cancer. According to the press release issued by Novo Nordisk (NYSE:NVO); “The US prescribing information includes a boxed warning for the risk of thyroid c-cell tumours. In preclinical testing, Victoza® caused thyroid c-cell tumours in rodents. In clinical trials there were no reported cases of medullary thyroid carcinoma (MTC) in patients treated with Victoza®, but human relevance of the rodent findings could not be ruled out by clinical or nonclinical studies. Victoza® is contraindicated in patients with a personal or family history of MTC or Multiple Endocrine Neoplasia syndrome type 2.”

According to the FDA’s press release; “In addition to a cardiovascular safety study to specifically evaluate the cardiovascular safety of Victoza in a higher risk population, the company also is required to conduct a 5-year epidemiological study using a health claims database to evaluate thyroid and other cancer risks as well as risks for seriously low blood glucose levels (hypoglycemia), pancreatitis, and allergic reactions. To specifically evaluate the risk of medullary thyroid cancer, the company is required to establish a cancer registry to monitor the rate of this type of cancer in the United States over the next 15 years.”

Looking over what the FDA stated and what Novo stated there are some additional interesting disconnects. According to Novo; “In the US, Victoza® is indicated as an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes. This provides for Victoza® to be used in monotherapy, as second-line treatment and in combination with commonly prescribed oral medications for diabetes.”

Yet according to the FDA; “Victoza is intended to help lower blood sugar levels along with diet, exercise, and selected other diabetes medicines. It is not recommended as initial therapy in patients who have not achieved adequate diabetes control on diet and exercise alone.”

The FDA also noted; “In five clinical trials involving more than 3,900 people, pancreatitis (inflammation of the pancreas) occurred more often in patients who took Victoza than in patients taking other diabetes medicines. Victoza should be stopped if there is severe abdominal pain, with or without nausea and vomiting, and should not be restarted if pancreatitis is confirmed by blood tests. Victoza should be used with caution in people with a history of pancreatitis.”

It’s interesting to note that there is no mention of the pancreatitis issue anywhere in the Novo release, imagine that.

As Diabetic Investor reported last week given what’s at stake here Novo is not above using any and all means to establish Victoza® in the US, even if that means muddying the waters over the entire GLP-1 category. Diabetic Investor highly recommends that everyone not only compare the press releases issued by Novo and the FDA but take the additional time to review the Questions and Answers – Safety Requirements for Victoza which is also available on the FDA web site. For your convenience we have provided the links to all three areas below.

Although Diabetic Investor does not plan on listening to the live version of the Novo conference call which is scheduled for 2am EST tomorrow morning. We will listen to the replay with great interest to see how the company plans on marketing a drug that comes to market with a black box warning. It will be equally interesting how they will explain away the FDA’s statement regarding pancreatitis, especially when one looks at the data compared to Byetta or Byetta LAR. Looked at side by side one would have to conclude that Byetta LAR is looking better and better.