Monday, March 4, 2013
FDA documents detailing its review of the diabetes drug
Bydureon exenatide indicate the agency delayed approval by a year and a half
after concluding the drug's sponsor, Amylin Pharmaceuticals Inc., had
intentionally and deceptively withheld data from a QT study that agency
officials believed raised serious concerns about the product's safety.
According to documents
previously made public, and new documents released last week at BioCentury's
request, FDA learned about the QT study shortly before it planned to approve
Bydureon. The regulators reversed course, holding up approval until the company
demonstrated QT safety.