Byetta Must Undergo Additional Safety Studies, FDA Says

<"http://www.yourlawyer.com/topics/overview/byetta_pancreatitis">Byetta, Amylin Pharmaceuticals’ type 2 diabetes drug, is undergoing more safety studies. The Food & Drug Administration (FDA) is requiring the additional Byetta studies to asses the drug’s risk of inflammation of the pancreas, acute renal failure and thyroid neoplasms.

Byetta was approved in 2005 to help type 2 diabetics on other medications better control blood sugar when other drugs were not adequate. The twice-daily injection is a synthetic form of a lizard hormone that boosts the production of insulin. Insulin is vital to controlling blood sugar levels. Just this past October, Byetta was approved as a stand-alone therapy for type 2 diabetes.

In August 2008, the FDA and Amylin announced six patients taking Byetta had died from pancreatitis. When the FDA approved the expanded use of Byetta, it also announced that the drug’s prescribing information would warn about the risk of pancreatitis in patients with severe kidney disease. In November, the agency approved a new label for Byetta amid reports the medicine may cause kidney problems.

The FDA’s request for new Byetta safety studies was made public yesterday after a Citigroup analyst said in a note to investors that he had seen the letter the FDA sent Amylin in October approving the expanded used of Byetta. According to Bloomberg.com, when Amylin announced the expanded Byetta approval, it made no mention of the additional studies.

According to a Reuters report, the FDA is requiring the drug maker to conduct the following studies:

*A epidemiological study on acute pancreatitis in Byetta versus non-Byetta patients

*Eidemiologic queries on pancreatic cancer and thyroid neoplasm in Byetta versus patients taking certain alternative therapies

*A clinical trial to see whether Byetta may increase the risk of gall bladder gallstones and therefore pancreatitis

According to Reuters, thyroid neoplasms usually refer to cancer of the thyroid.

According to a statement Amylin released yesterday, some of the studies required by the FDA have already begun. The company maintained that so far, none have shown an increased risk of pancreatitis.

That did little to quell investor concerns however, and Amylin stock fell nearly 10 percent in trading yesterday. According to Bloomberg.com, that is the biggest drop for the stock in eight months of NASDAQ trading.

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