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Amylin Pharmaceuticals, Inc. Message Board

  • terry_amln terry_amln Nov 10, 2010 6:05 AM Flag

    Experts comment on FDA incompetence

    "My understanding is that the FDA wanted more data on Bydureon to be sure it was safe, not that there was any signal that it isn't safe," explained Anne Peters, MD, FACP, CDE, director of the University of Southern California Clinical Diabetes Program^^^^^^^The new drug application originally submitted by the companies in May 2009****In March 2010, the FDA issued an initial complete response letter no clinical trials were requested at that time.

    In an interview with Medscape Medical News, Alan J. Garber MD, PhD, commented that the FDA's request for additional QT data is a relatively unusual decision, noting that "what makes it unusual is that the product's been on the market for a number of years, and there's been no suggestion of arrhythmia or electrocardiographic change, so far as I know."

    He added, "it's one thing to have an exposure risk for things that are on the label already, such as pancreatitis...but this QT stuff is out of the blue. And so without knowledge of a prior precedent, I'm not sure what the agency is concerned about."

    Dr. Garber is professor of medicine, biochemistry, and molecular biology in the Molecular and Cellular Biology Division of Diabetes, Endocrinology, and Metabolism at Baylor College of Medicine in Houston, Texas.

    but if [the FDA] is concerned that there's a difference between the prototype and the actual marketed product, they may want to take a look at the data a bit more carefully," noted Dr. Garber.

    "I'm sure that once-weekly [dosing] is an improvement over once-daily [dosing] in terms of glucose control, and probably your patient persistence and adherence to the medication," said Dr. Garber, noting that no head-to-head study data of once-weekly exenatide and liraglutide are currently available.

    Dr. Peters, noting that existing data suggest the product is safe, the drug delivery system has been used with other drugs, and twice-daily exenatide has been on the market for about 5 years. "There is a certain comfort in all of that," she added.

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