Agency's critique surfaces as Big Pharma bids in Amylin auction.
Mary Parks, who runs the FDA's division responsible for diabetes treatments, contended in those documents that Amylin held back data about the cardiovascular side effects of Byetta at a time when the agency was determining whether to approve a longer-acting version, Bydureon. FDA officials only discovered those "concerning findings" about Byetta after Canadian regulators contacted them, Parks stated.
And even when FDA asked for the data, to add it to the Bydureon submission, Amylin submitted older documentation instead, Parks said. When the agency asked for a new study to check out the "concerning findings," Amylin stalled, according to the document. So, Bydureon's agency review was "long and complicated ... in part due to Amylin's withholding of information on Byetta that FDA deemed important to its evaluation of the safety and effectiveness of Bydureon."
As Amylin points out, FDA did eventually approve Bydureon. But that was only after an initial rejection. AsTheStreet reports, Amylin's deception didn't stop with FDA. Executives didn't disclose to investors that its held-back heart-safety data influenced the agency's earlier decision to reject the drug.
What will the Big Pharma bidders eyeing Amylin think about these allegations? Takeda, Merck, Sanofi, Pfizer, Bristol-Myers Squibb, AstraZeneca--all have been identified as Amylin shoppers. They might be a bit more diligent about their due diligence now.
- check out the FDA document
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- read the Financial Times story