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Amylin, Lilly diabetes drug delayed

The US Food and Drug Administration has requested that a new clinical study be added to the marketing application for diabetes drug Bydureon

The US Food and Drug Administration (FDA) has requested that a new clinical study be added to the marketing application for Bydureon (exenatide extended-release for injectable suspension), which is being developed through a partnership between Amylin Pharmaceuticals, Eli Lilly and Alkermes as a treatment for type II diabetes.

The drug is a once-weekly version of Amylin and Lilly's Byetta that is formulated with Alkermes' proprietary Medisorb technology for long-acting medications.

The FDA's complete response letter, which is the second that the federal agency has issued for the New Drug Application (NDA) that was submitted in May 2009, requests a QT study to evaluate the cardiovascular safety of levels of exenatide higher than typically used therapeutically.

"We have thoroughly assessed the EKG (electrocardiogram) data from the (phase III) DURATION programme and believe that Bydureon demonstrated no increased risk of cardiovascular complications due to QTc prolongation, arrhythmia or conduction disorders," Amylin President and CEO Daniel M. Bradbury said in a conference call discussing the FDA's request. "However, we believe that the recent attention drawn to the cardiovascular safety profiles of drugs for type II diabetes may have led to additional emphasis on the value of a positively controlled QT study to augment the data we provided in the May 2009 NDA filing."

Bradbury noted that the question of a QT study had not been raised in the FDA's first complete response letter for the NDA, which was issued in mid-March. That letter raised concerns about the  propriety manufacturing process for the drug; after the companies submitted their response, the FDA set October 22 as the action date for the NDA, but that has now been pushed back again by the new letter. The manufacturing issues were not raised again in the new letter, Bradbury noted.

"Subject to further discussions with the agency to gain agreement on the design of the QT study, our goal is to submit a reply to the complete response letter by the end of 2011," Bradbury said. "Based on the request for additional data, this will likely be considered a class 2 submission requiring a six-month review."

However, the CEO said the companies "remain confident" in the product and "will continue to work diligently to bring it to market."

21st October 2010

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