Byetta Pancreatitis Concerns Could Delay Long-Acting VersionAug 28, 2008 | Parker Waichman LLP
A much-anticipated long-acting form of Byetta might have problems gaining approval now that the current form of the diabetes drug has been associated with pancreatitis. Amylin Pharmaceuticals had hoped that once-weekly Byetta would be approved by 2010, but now there is a good chance that the Food & Drug Administration (FDA) will want more information on the medication's side effects before it makes a decision.
Byetta was approved by the FDA in 2005 to help type 2 diabetics 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.
Last week, the FDA said that Byetta - in its current form - had been linked to 6 cases of hemorrhagic or necrotizing pancreatitis in patients taking Byetta since its October alert. All patients required hospitalization, two patients died and four patients were recovering at time of reporting. Byetta was discontinued in all 6 cases. Late Tuesday, Amylin announced that four additional fatalities had been confirmed in Byetta patients suffering from milder forms of pancreatitis.
Just last October, the FDA said that 30 people developed pancreatitis that was associated with the use of Byetta. Of those, 5 later suffered from kidney failure. Six patients experienced the onset or worsening of symptoms after their dosage of Byetta was increased from 5 milligrams twice daily to 10 milligrams twice daily. And according to the FDA, pancreatitis symptoms in 22 patients subsided or improved once they quit taking Byetta.
Because of its long-acting nature, once-weekly Byetta cannot be quickly removed from the body, which would be a problem for a patient who developed pancreatitis. In most instance where Byetta patients develop pancreatitis, the problem subsides once treatment is halted. That would not likely be the case with the long-acting version.
These concerns could mean that the new form of the drug will face tougher scrutiny from the FDA. One hint of the agency's attitude towards the new version could come when label revisions for current Byetta are made public. The agency wants to "add stronger and more prominent warnings" about the risk of severe pancreatitis to Byetta's label. According to Dow Jones News Service, changes to the label could vary from stronger wording, a change of font or, in the worse-case scenario, a black-box warning. The severity of the change could lead to a tougher review of once-weekly Byetta.