Agency wants the studies to asses the drug’s risk of inflammation of the pancreas, acute renal failure and thyroid neoplasms. The Food & Drug Administration (FDA) is requiring Amylin Pharmaceuticals to conduct more safety studies of its type 2 diabetes drug, Byetta. The agency wants the studies to asses the drug’s risk of inflammation of the pancreas, acute renal failure and thyroid neoplasms.
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 expanded used of Byetta.
“The FDA considers post-marketing reports of acute pancreatitis (fatal and non-fatal hemorrhagic or necrotizing pancreatitis), acute renal failure and thyroid neoplasms as ‘new safety information’ and is requiring Amylin to conduct additional studies,” the FDA letter said.
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
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.
Byetta was approved in 2005 to help type 2 diabetics on other medications better control blood sugar when other drugs were not adequate. Just this past October, Byetta was approved as a stand-alone therapy for type 2 diabetes.
In August 2008, the FDA issued a health alert announcing that 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.
According to Bloomberg.com, when Amylin announced the expanded Byetta approval, it made no mention of the additional studies.