tagged w/ pancreatitis
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The Food and Drug Administration yesterday reported that six people with type 2 diabetes, who were taking Amylin Pharmaceuticals' drug Byetta to control their blood sugar, developed a severe inflammation of the pancreas.
Two of the six people died.
Although the regulatory agency did not make a link between the drug and pancreatitis, investors sent shares of San Diego-based Amylin down more than 13 percent, or $4.45, to close at $29.76.
Analysts speculated that sales of Byetta, the company's lead product, could drop and Amylin could have a tougher time getting a once-weekly version of the drug approved for market.
Amylin, which markets Byetta in partnership with Eli Lilly & Co., pointed out that people with type 2 diabetes are at higher risk for pancreatitis than the general population.
“The proportion of cases reporting complications or fatal outcome is similar to that observed in the general population with pancreatitis,” Amylin said in a statement.
Nonetheless, the company said it would work with the FDA to “ensure that our Byetta product label continues to provide physicians and patients with information about the risk of pancreatitis.”
“In accordance with our strict internal processes, we continuously monitor and notify regulatory authorities of adverse events reported during the use of any of our drugs,” the company's statement said.
The FDA's note is the second in 10 months about people taking Byetta developing pancreatitis. In October 2007, the FDA said 30 patients who had been prescribed Byetta had reported less severe cases.
Byetta, on the market since 2005, is the top seller of Amylin's two diabetes drugs. Its sales rose 17 percent in the second quarter over the same quarter last year. Although analysts were initially skeptical about Byetta's appeal in the marketplace because it requires twice-a-day injections, the company has said more than 1 million people have been prescribed the drug.
And a once-a-week version of the drug is in development.
Since this long-acting version of the drug stays in the body longer after one dose and can't be “turned off” if pancreatitis develops, the FDA may have concerns about the condition when it considers the drug for approval, Tim Anderson, an analyst at Sanford C. Bernstein & Co. in New York, said in a note to investors.
But he said he still expects its approval in 2010 and U.S. sales of $1.5 billion by 2015.
A local diabetes expert said yesterday he is not convinced that Byetta played a role in the people developing pancreatitis.
“People who are type 2 diabetics have a high triglyceride level, a leading cause of pancreatitis,” said Steven Edelman, a doctor and professor of endocrinology, diabetes and metabolism internal medicine at the University of California San Diego Medical School.
Edelman said he has prescribed Byetta to hundreds of patients. Its advantage over other drugs is that it helps patients lose weight, he said. Other type 2 diabetes medications make patients gain weight, a problem in a disease linked to obesity.
Edelman further suggested that data from Byetta's clinical trial may even support the theory that it might prevent pancreatitis: of thousands of people who took Byetta in the clinical trial, three developed pancreatitis while six people taking a placebo developed pancreatitis.
“However, I think it is super important that the company and FDA monitor this thing closely to be sure,” Edelman said.The Food and Drug Administration yesterday reported that six people with type 2... more
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