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Novo Nordisk is committed to patient safety and rejects Public Citizen's assertion that the benefits of Victoza® are outweighed by its risks. Moreover we feel that the comparison in this article to the glitazone class is inappropriate because of different mechanisms of action.
When it approved Victoza® two years ago, the US Food and Drug Administration had before it a large amount of data, including clinical trials in nearly 4,000 patients. As part of its usual process, it carefully assessed all of the data and approved Victoza® with labeling that informs physicians and people with diabetes about the appropriate use of the product.
In the two years since Victoza® was approved, Novo Nordisk has conducted a continuous surveillance of adverse events and has continued to work closely with the FDA and the medical community to monitor risks and the appropriate use of Victoza®. We have provided updates to patients and the medical community and will continue to do so on a regular basis.
Our experience in those two years does not support the Public Citizen call to deprive patients of the benefits of Victoza®. Indeed, the FDA just recently approved the expanded use of Victoza®. In addition, Victoza is approved in 52 countries with more than 550,000 years of patient exposure. Safety is independently monitored by all regulatory agencies.
Novo Nordisk wants to assure patients taking Victoza® and healthcare professionals who care for them that they should remain confident in its safety.
Competing interests:
Global Chief Medical Officer for Novo Nordisk
Re: Consumer group calls for antidiabetes drug to be withdrawn
Novo Nordisk is committed to patient safety and rejects Public Citizen's assertion that the benefits of Victoza® are outweighed by its risks. Moreover we feel that the comparison in this article to the glitazone class is inappropriate because of different mechanisms of action.
When it approved Victoza® two years ago, the US Food and Drug Administration had before it a large amount of data, including clinical trials in nearly 4,000 patients. As part of its usual process, it carefully assessed all of the data and approved Victoza® with labeling that informs physicians and people with diabetes about the appropriate use of the product.
In the two years since Victoza® was approved, Novo Nordisk has conducted a continuous surveillance of adverse events and has continued to work closely with the FDA and the medical community to monitor risks and the appropriate use of Victoza®. We have provided updates to patients and the medical community and will continue to do so on a regular basis.
Our experience in those two years does not support the Public Citizen call to deprive patients of the benefits of Victoza®. Indeed, the FDA just recently approved the expanded use of Victoza®. In addition, Victoza is approved in 52 countries with more than 550,000 years of patient exposure. Safety is independently monitored by all regulatory agencies.
Novo Nordisk wants to assure patients taking Victoza® and healthcare professionals who care for them that they should remain confident in its safety.
Competing interests: Global Chief Medical Officer for Novo Nordisk