Diabetes drugs including Merck & Co. (MRK)’s Januvia, Bristol-Myers Squibb Co. (BMY)’s Byetta and Novo Nordisk A/S (NOVOB)’s Victoza are being scrutinized by U.S. regulators for a potential link to pancreatic cancer.
The Food and Drug Administration is reviewing unpublished findings by a group of academic researchers that suggest pre- cancerous cellular changes may be associated with Type 2 diabetes drugs called incretin mimetics, according to a statement today from the agency. The findings suggest the class of medicines may be linked to the risk of developing an inflammation of the pancreas tied to cancer and kidney failure that was previously reported in some of the medicines.
Doctors have been concerned that this category of diabetes treatments may damage the pancreas since the FDA said in 2007 it received a high number of reports of pancreatitis in patients taking Byetta. The agency issued a similar alert for Januvia in 2009. An analysis of insurance records published last month in the journal JAMA Internal Medicine showed such drugs may double a user’s risk of pancreatitis.
The drugs in the class include exenatide, liraglutide, sitagliptin, saxagliptin, alogliptin and linagliptin. They mimic incretin hormones that the body usually produces naturally to stimulate the release of insulin in response to a meal, the FDA said.
The FDA said it hasn’t reached any new conclusions about the safety risks associated with the drugs and hasn’t determined whether they may cause or contribute to pancreatic cancer. The agency suggested patients continue taking the drugs and talk with their doctors.
Merck, the second-largest U.S. drugmaker, is confident in the safety of sitagliptin, which is found in Januvia as well as the company’s Janumet and Juvisync, Pamela Eisele, a spokeswoman, said in an e-mail. The Whitehouse Station, New Jersey-based company reviewed all the safety data available to them on sitagliptin and “find no compelling evidence establishing a causal relationship between the use of sitagliptin and pancreatitis or pancreatic cancer,” Eisele said.
Merck will continue to monitor the safety of the drug with regulatory agencies and scientific experts, she said.
Merck reported $4 billion in sales, or about 9 percent of total revenue, from Januvia last year. The daily pill blocks an enzyme that breaks down GLP-1. Janumet, which combines Januvia with the older diabetes drug metformin, generated $1.7 billion in sales last year.
Bristol-Myers, based in New York, acquired Byetta last year when it bought Amylin Pharmaceuticals. Byetta, which mimics GLP-1, had sales of $148 million for Bristol-Myers last year, and $159 million for Indianapolis-based Eli Lilly & Co. (LLY), which ended its marketing partnership with Amylin in 2011.
Novo Nordisk’s Victoza generated about $1.6 billion in sales, according to data compiled by Bloomberg.
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