Bydureon back story

New disclosures about FDA-Amylin dispute over safety of Bydureon for diabetes

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.

Amylin says the study that provoked FDA's concerns did not indicate any safety issues, that the company did not hide the data from FDA, and that the agency needlessly delayed approval of Bydureon.

EMA, as well as FDA's own CV experts, looked at the same data and determined that any uncertainty about Bydureon's cardiac safety could be addressed after approval.

Nevertheless, FDA's Division of Metabolism and Endocrinology Products, supported by agency senior management, determined that Amylin had to run a new QT study prior to approval.

The regulatory delay almost certainly played a major role in Eli Lilly and Co.'s decision to terminate its Bydureon partnership with Amylin, and in the biotech's acquisition by Bristol-Myers Squibb Co. in August 2012.

Beyond the specific events, the Bydureon review documents illuminate FDA's regulatory philosophy, highlighting the agency's reluctance to accept uncertainty about the safety of new drugs that it considers incremental improvements over existing therapies.

While the events in the Bydureon story unfolded between February 2010 and January 2012, last week's FDA complete response letter for Heplisav HBV vaccine from Dynavax Technologies Corp. shows the agency's philosophy has not changed.

Moreover, last week's safety-related recall of Omontys peginesatide likely ensures that drugs will continue to receive withering scrutiny when they are deemed to provide incremental benefits for large, heterogeneous populations.

As its primary benefit, the anemia drug from Affymax Inc. and Takeda Pharmaceutical Co. Ltd. offered a dosing advantage over marketed alternatives (see "Two-Speed System," A7).

Study GWCI

Bydureon, a glucagon-like peptide 1 analog, was developed by Amylin in partnership with Lilly, using

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