The prominent consumer advocacy group Public Citizen is urging the FDA not to expand approval of the diabetes drug Victoza for use as a weight loss treatment, indicating that the medication is already too dangerous due to the increased risk of thyroid cancer, pancreatitis and cardiovascular concerns.
Public Citizen officials testified before the FDA Endocrinologic and Metabolic Drugs Advisory Committee on September 11, indicating that the Victoza risks outweigh any potential benefits as a weight loss drug.
Repackaging Victoza As Patent Protection Runs Out
Victoza is currently available as a diabetes drug, containing the active pharmaceutical ingredient liraglutide. Novo Nordisk is proposing a new higher-dose version of the drug, which would be marketed as Saxenda, seeking approval to market the medication as a weight-loss aid.
“Because of its myriad risks, liraglutide is currently second-line therapy for (diabetes) at a dose of 1.8 mg/day,” Public Citizen officials testified. “As Victoza nears the end of its market exclusivity, Novo Nordisk will undoubtedly shift its marketing strategy towards the 3.0 mg/day Saxenda, including for use in overweight/obese diabetic patients, with an aim to ‘transition’ as many (diabetes) Victoza users as possible to the more lucrative Saxenda as a first-line weight loss therapy.”
Novo Nordisk first unveiled its plans to promote Victoza as a weight loss drug this summer, at a conference of the American Diabetes Association.
The drug maker claims that trials show that Victoza patients lost 5.9% of their body weight after being given daily 3 mg injections. Patients given a placebo and placed on the same program of dieting and exercise only lost 2%.
Just a week before that conference, Public Citizen urged the FDA to recall Victoza from the market entirely, saying it carries too high a risk of acute pancreatitis for diabetes patients. However, Novo Nordisk appears ready to double-down on the drug, pushing potential new uses.
Victoza Side Effects
Victoza was first approved by the FDA in January 2010 for the treatment of type 2 diabetes. The Novo Nordisk drug is a member of a class of diabetes drugs known as incretin mimetics, which also includes the blockbuster treatments Byetta, Januvia, Janumet and others.
At the time the medication was first introduced, at least two FDA pharmacologists and one clinical safety reviewer advised against the approval of Victoza as a diabetes treatment, suggesting that the risks may outweigh the benefits provided over other available treatments for type 2 diabetes.
A number of studies have linked side effects of Victoza and other drugs from the same class to serious and potentially life-threatening risks.
The Victoza warning label warns that there may be a risk of thyroid cancer associated with the medication, and researchers have also suggested that users may face an increased risk of pancreatitis, which could lead to the development of pancreatic cancer for some users.
Public Citizen points out that pre-marketing studies of high-dose Victoza led to subjects experiencing nausea, vomiting, pancreatitis and thyroid cancer. The drug also appeared to increase the heart rate.
FDA reviewers raised questions over the cardiovascular (CV) risks of Victoza in a pre-meeting briefing (PDF), saying that they may outweigh any benefits from weight loss. The reviewers pointed to a number of recent studies that failed to find any cardiovascular benefit to approved weight loss drugs.
“These findings raise the concern that a pharmacological effect on weight loss may not provide enough assurance of a CV benefit to offset a CV safety issue (such as increased heart rate) associated with a weight loss drug,” the reviewers warned.
The reviewers pointed out that there were seven cases of pancreatitis among high-dose Victoza users and only one case among those given a placebo. All of the Victoza cases were severe, the placebo control case was not.
Pancreatic Cancer Lawsuits Over Victoza
The push to expand use of the medication for weight-loss comes amid a mounting number of Victoza lawsuits being filed in courts nationwide on behalf of former users diagnosed with pancreatic cancer. Similar allegations have been raised in hundreds of other Byetta lawsuits, Januvia lawsuits and Janumet lawsuits, claiming that the entire incretin mimetic class of drugs increases the risk of pancreatic cancer for diabetics.
Byetta (exenatide) was the first member of the incretin mimetic class of diabetes drugs, which was introduced by Amylin Pharmaceuticals in 2005 as a twice daily injection.
Novo Nordisk introduced Victoza in 2010, as a longer acting injectable diabetes drug and Amylin introduced Bydureon (exenatide extended-release) in January 2012 as a once-weekly version of Byetta.
Januvia (sitagliptin) was introduced by Merck as an oral incretin mimetic diabetes drug in 2006, and has become one of the most widely used members of the class. A combination pill containing Januvia and the older diabetes medication metformin was introduced in 2007 under the brand name Janumet.
Given the similar allegations raised in lawsuits over the diabetes drugs, the U.S. Judicial Panel on Multidistrict Litigation (JPML) established consolidated proceedings in the federal court system for these cases in August 2013.