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Two drug manufacturers are planning to present data on a number of new studies involving the effectiveness and safety of a class of diabetes drugs that includes Byetta and Januvia, which have been the subject of increasing concerns about a risk of pancreatic cancer.
AstraZeneca and Bristol-Myers Squibb announced on June 14 that they will present summaries for 33 different studies involving the diabetes drugs Byetta, Bydureon, Onglyza, Kombiglyze XR, and Symlin.
Byetta, Bydureon, Onglyza and Kombiglyze XR (a combination of Onglyza and metaformin) are all part of a class of medications known as incretin mimetics, which have been linked to a potential increased risk of acute pancreatitis and reports pancreatic cancer. Symlin is the sole member of a class of drugs known as an amylin analog.
The summaries, known as abstracts, will be presented at the 73rd Scientific Sessions of the American Diabetes Association (ADA). The conference will be held in Chicago from June 21 through June 25. The abstracts are being presented by the AstraZeneca and Bristol-Myers Squibb U.S. Diabetes Alliance. The studies will also include data on the experimental drug dapagliflozin, which is already in use in Europe and a number of countries around the world.
“The diversity of data reflects our joint commitment to researching and delivering innovative medicines and treatment options to help patients overcome the burdens of diabetes,” said the Alliance’s vice president and head of Medical Affairs, Dr. John Yee.
The announcement came just days after the ADA called for an independent review of the potential pancreatic cancer side effects of incretin mimetics, which also includes the blockbuster medications Januvia, Janumet, and Victoza, among others.
On June 10, the ADA called for the companies involved with incretin mimetic medications to release all patient-level data involving their medications so that it may be independently reviewed to address the potential link between Byetta, Victoza, Januvia and pancreatic cancer.
The call appears to be urging the companies to take actions similar to those taken by Medtronic, which released all patient-level data on its Infuse bone growth product for independent review after harsh criticism for unduly influencing previous medical studies. Those independent reviews were released earlier this week and raised questions about the safety and effectiveness of the bone graft device.
Diabetes Drug Pancreatic Cancer Concerns
Incretin mimetics are a relatively new class of diabetes drug, which work by mimicking the incretin hormones that the body usually produces to naturally stimulate the release of insulin in response to a meal.
Byetta (exenatide) was the first member of this class approved by the FDA, introduced by Amylin Pharmaceuticals and Eli Lilly in 2005 as a twice daily injection.
Januvia is the most widely used member of the class, which was introduced by Merck in 2006 as an oral medication. A combination pill containing Januvia and metformin was introduced in 2007, under the brand name Janumet. Victoza (liraglutide) was introduced by Novo Nordisk in 2010 as a daily injection.
Concerns about the side effects of Byetta, Januvia, Janumet and Victoza and their possible link to pancreatic cancer has increased among consumers and the medical community since the FDA issued a statement in March that it was reviewing the findings of a study that identified pre-cancerous cellular changes among users of the medications. European health officials have also launched a similar review.
A growing number of Januvia lawsuits, Janumet lawsuits, Byetta lawsuits and Victoza lawsuits have been filed in courts throughout the country by individuals diagnosed with pancreatic cancer after using the medications. The complaints allege that the drug makers have ignored signs that the medications increase the risk of pancreatitis, which could ultimately lead to pancreatic cancer.