Victoza® and the FDA

Victoza® and the FDA

There are just certain things that Diabetic Investor has never been able to figure out and the FDA tops the list. The fact is no one is quite sure what the agency will do or the reasons behind their actions. This feeling was reinforced today after Diabetic Investor read an article that appeared in the online version of the New England Journal of Medicine. Written by Mary Parks, M.D. director, Division of Metabolism and Endocrinology Products in the FDA’s Center for Drug Evaluation and Research and Curtis Rosebraugh, M.D., M.P.H. director of the FDA’s Office of Drug Evaluation. The article is entitled “Weighing Risks and Benefits of Liraglutide – The FDA’s Review of a New Antidiabetic Therapy”

After reading the article Diabetic Investor wasn’t quite sure just what Dr. Parks and Dr. Rosebraugh were trying to accomplish. The article did not reveal any new information about Victoza® nor did it clear up any of the questions surrounding the drug. In fact one could argue the article raises even more questions as the authors note “there are potentially serious safety concerns” with Victoza, which would call into question why the FDA approved the drug in the first place.

In a great example of government double speak the authors go onto state; “The FDA concluded that increases in the incidence of carcinomas among rodents translated into a low risk for humans, because statistically significant increases occurred only at drug exposure levels many times those anticipated in humans, and the increase in cancers did not affect overall survival rates. However, it is difficult to extrapolate findings from studies in animals to humans.”  Translation the FDA isn’t quite sure what the heck will happen to patients using Victoza over the long term.

The authors close the article by stating; “In approving liraglutide, the FDA recognized that it may benefit patients who have inadequate diabetes control despite their use of another antidiabetic therapy. Improved glycemic control significantly reduces the risk of microvascular complications from diabetes and is a cornerstone of diabetes treatment. The FDA also recognizes that all products approved for treating type 2 diabetes, including long-marketed products, carry risks. Several of liraglutide’s potential safety problems will be studied further. A risk evaluation and mitigation strategy is required that includes a medication guide and a communication plan for educating prescribers about the drug’s risks and benefits and the fact that it is not recommended as first-line therapy for patients whose diabetes has not proven controllable with diet and exercise. The FDA expects to learn more about liraglutide’s safety from the required post approval studies and clinical trials. In the interim, physicians will need to carefully review the prescribing information and decide whether the benefit–risk profile is favorable for each individual patient.” Highlighting added by Diabetic Investor.

So if we understand what the authors are saying is that Victoza may have some benefits but the carries with it several possible safety problems but not to worry as they’ll learn more when the post approval studies, which will take years, are completed. In the meantime physicians should proceed at their own risk.  While Diabetic Investor can’t speak for Novo Nordisk (NYSE:NVO) who makes Victoza, we suspect this was not the message they were hoping for.

The fact that the FDA felt it necessary to explain their action with Victoza should send the clearest message of all. To Diabetic Investor this fact alone shows that the FDA is not comfortable with their decision and is now in major CYA mode. What Diabetic Investor does not understand is why the FDA, with all the unanswered surrounding Victoza, felt it necessary to approve the drug. Are the current therapy options for patients with type 2 diabetes so inadequate that the FDA felt compelled to approve a drug with possible safety concerns? Would it hurt to have asked Novo to conduct further studies to clarify these “potentially serious safety concerns”?

The fact is the FDA’s primary responsibility is to protect the public and that no drug should be approved if there are any questions about its safety; especially when there are “serious safety concerns.” Telling a physician to “carefully review the prescribing information and decide whether the benefit–risk profile is favorable for each individual patient” does little to ease the concerns these physicians have and who’s primary responsibility is to do no harm.

The bottom line with Victoza is the more we learn the more questions we have.  This is not good news for the folks at Novo who have been desperately trying to tell everyone that the concerns surrounding Victoza are no big deal. That the black box warning is really nothing to be concerned about and that the FDA was just being overly cautious. As Diabetic Investor has noted on several questions patients and the physicians who treat want a simple answers when it comes to drugs used to treat their diabetes. In the end they want to know if the drugs they are taking every day of their lives are safe.

In the real world patients and physicians want some degree of clarity. They understand that all drugs carry some degree of risk; they just want to make sure these risks are reasonable. All the FDA has done here is create more questions. Instead of adding clarity they added confusion to an already messy situation. The bottom line here is that when asked by a patient if this drug is safe, the physician cannot answer with a simple yes or no. This is not good news for either the FDA or Novo.