Amid Petition to Recall Victoza, Novo Nordisk Plans Big Expansion
Novo Nordisk continues to explore a variety of new uses for their controversial diabetes drug Victoza, despite a push by the consumer watchdog group Public Citizen to have the drug recalled from the market due to the risk of pancreatitis and other side effects.
On June 14, the drug manufacturer issued a press release announcing that a combination of Victoza and Tresiba, a form of insulin, is both safe and effective at lowering glucose level in diabetics.
At a conference of the American Diabetes Association that day, the company called the effectiveness of the combination drug, IDegLira, “unprecedented.”
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At the same conference, another study was presented that suggests Victoza could work as an effective weight loss drug, with patients showing a 5.9% loss of body weight after being given daily injections of 3 milligrams along with a program of dieting and exercise. Patients given a placebo and placed on the same program only lost about 2%.
That study’s findings have not yet been published.
Just a week before the conference, Public Citizen urged the FDA to ban Victoza from the market, saying it carries too high a risk of acute pancreatitis for patients. However, Novo Nordisk appears ready to double-down on the drug with potential new uses.
Victoza (liraglutide) was 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 Byetta, Januvia, Janumet and others. Two FDA pharmacologists and one clinical safety reviewer advised against the approval of Victoza at the time it was proposed by the drug maker.
A number of studies have linked Victoza and similar drugs to an increased risk of pancreatic cancer, which is often deadly. However, following an investigation the FDA has dismissed those claims, saying it found no increased pancreatic cancer risk. The agency also rejected an earlier petition by Public Citizen to issue a Victoza recall.
Public Citizen’s most recent call for a Victoza recall came following a study that found 278 case reports of Victoza acute pancreatitis at current dosing levels. The group notes that those are likely just a fraction of the actual pancreatitis cases. The group warns that shots for weight loss purposes would likely require a much larger dose that could increase the risk of Victoza side effects.
Novo Nordisk has defended the drug, and reported on the findings of another study at the conference that indicated that Victoza was safe for patients suffering kidney problems.
Diabetes Drug Litigation
Amid mounting concerns about the link between the diabetes drugs and cancer, hundreds of Victoza lawsuits, Byetta lawsuits, Januvia lawsuits and Janumet lawsuits have been filed by individuals throughout the United States who claim that they were diagnosed with pancreatic cancer after using the drugs.
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.
There are currently more than 440 complaints centralized before U.S. District Judge Anthony J. Battalglia in the Southern District of California to reduce duplicative discover, avoid conflicting pretrial rulings from different judges and to serve the convenience of the parties, witnesses and the courts.
It is expected that a small group of cases in the federal Multidistrict Litigation (MDL) will be prepared for early trial dates, known as “bellwether” cases because they will be used to gauge how juries may respond to certain evidence and testimony on the link between increatin mimetics and pancreatic cancer. The first cases are unlikely to reach a jury before late 2015 or early 2016.
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