FDA issues new Byetta alert on more serious pancreatitis cases
This article was originally published in Scrip
The US FDAhas alerted US doctors to the fact that Lillyand Amylin's injectable type 2 diabetes drug Byetta (exenatide) has been associated with six cases of haemorrhagic or necrotising pancreatitis – and that of the six cases, two patients died and four are recovering.
The alert, on its MedWatch site, follows a communication last autumn, when US regulators focused on suspected links between the product and 30 cases of acute pancreatitis, but emphasised that they had no postmarketing reports of haemorrhagic or necrotising pancreatitis (Scrip Online, October 17th, 2007). At that time, Amylin agreed to include information about acute pancreatitis in the precautions section of Byetta's label. The product, a first-in-class incretin mimetic, has been available in the US since 2005.
Now, the FDA said it is working with Amylin to add "stronger and more prominent" warnings to Byetta's label about the risk of pancreatitis, an inflammation of the pancreas.
The FDA said there were no signs or symptoms that distinguish acute haemorrhagic or necrotising pancreatitis associated with Byetta from the less severe form of the condition. It added that the use of Byetta was discontinued in all cases and that patients with a history of pancreatitis should consider alternative diabetes therapies.
In the previously reported, less severe cases, the FDA had said that 27 of the 30 patients had at least one other risk factor for developing the condition. 21 of those patients were hospitalised.
With reports of new cases, Amylin has said that diabetes patients in general have an increased risk of pancreatitis. Patients taking Byetta are not at a greater risk of rare, serious complications.
Lilly and Amylin are working on a once-weekly version of Byetta, Byetta LAR, with Alkermes. While the complication of pancreatitis seems rare, Sanford Bernstein analyst Timothy Anderson has said that fewer than 300 patients have been studied with the once-a-week version, and thus the "FDA may worry about LARS's effects once it is approved and used in a broader, less closely monitored, patient population. To us, this creates regulatory risk with Byetta LAR."