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Approval of Long-Acting Byetta Hits Snag

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Amylin Pharmaceuticals said yesterday that approval of a new version of Byetta – the diabetes drug it sells with Eli Lilly & Co. – will likely be delayed.  The company said in a regulatory filing that the Food & Drug Administration (FDA) had rejected some of the Byetta data that was submitted to the agency.

According to Amylin’s filing with the Securities and Exchange Commission (SEC),the FDA rejected data from studies meant to show that new Byetta batches made by partner Alkermes were equivalent to batches made at Amylin’s Ohio facility. If Amylin has to conduct an additional study, it would likely delay its plans to ask for approval by the middle of 2009. Amylin said it is continuing discussions with the FDA.

The original 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.  The new version of Byetta would be taken once-weekly.Even the current version has had its share of problems.   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.  Then, on August 26, Amylin announced that four additional fatalities had been confirmed in Byetta patients suffering from milder forms of pancreatitis.

It is still not known what effect those safety concerns will have on the approval prospects for the new version of Byetta.

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