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Another Byetta Delay

Dec 9, 2008 | Parker Waichman LLP

Federal regulators are extending a review of the diabetes drug Byetta into next year, Forbes.com is reporting.  The Food & Drug Administration (FDA) is considering whether or not to approve Byetta as a stand-alone treatment for diabetes.  Right now the drug, jointly marketed by Amylin Pharmaceuticals and Eli Lilly, is approved for use in combination with other diabetes medications to help people with type 2 diabetes control their blood sugar.

Byetta has been the subject of safety concerns for some time.  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.

Then on August 18, the FDA said that Byetta 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. Finally on August 26, Amylin announced that four additional fatalities had been confirmed in Byetta patients suffering from milder forms of pancreatitis.

Amylin and Lilly submitted an application to have Byetta approved as a stand-alone therapy in the first quarter of 2008, Forbes.com said.  The companies said the FDA did not request any additional studies.  According to Reuters.com, the agency is reviewing several Byetta prescribing information updates submitted by the companies, including revision of safety language.

Another version of Byetta - a long-acting formula - had already been delayed, partly  because of the safety concerns surrounding the drug. In a filing with the Securities and Exchange Commission (SEC) last month,  Amylin said data submitted for the approval of long-acting Byetta didn’t satisfy the FDA’s  standards. In the filing, Amylin said that if the FDA required it  to conduct an additional study, it would likely delay its plans to ask for approval by the middle of 2009.

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 instances where Byetta patients develop pancreatitis, the problem subsides once treatment is halted.  That would not likely be the case with the long-acting version.

Byetta was approved by the FDA in 2005.  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.


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