Amylin withheld safety data, says FDA
pharmafile | June 27, 2012 | News story | Research and Development, Sales and Marketing | Amylin, Bydureon, Byetta, FDA, lilly
The US medicines regulator says Amylin held back data relating to the safety of its diabetes drug Bydureon.
The allegation is contained in a newly-published FDA document which outlines the regulator’s concerns about Amylin’s conduct.
Mary Parks, division director for diabetes medicines at the FDA, discusses in detail in the recently released document how Amylin withheld data relating to Byetta (exenatide) and its long-acting version, Bydureon.
The overall conclusion of the review is favourable for Amylin, as the FDA cleared the drug for use, but it says the firm’s withholding of information obstructed the process.
“The review and this eventual recommendation for approval of Bydureon has been a long and complicated process, in part due to Amylin’s withholding of information on Byetta that FDA deemed to be important to its evaluation of the safety and effectiveness of Bydureon,” remarked Parks.
The FDA agreed to rely on safety and effectiveness data for Byetta when reviewing Bydureon, but says Amylin did not present it with all relevant data.
A study of electrocardiograms measuring the QT interval, a heart’s electrical cycle commonly monitored to detect drug side effects, had raised some concerns.
But the FDA says it was only made aware of ‘concerning findings’ by counterparts at Canada’s medicines regulator.
“What knowledge Amylin had of Byetta should have been submitted to FDA in a transparent manner to fully disclose any areas that needed to be considered in the benefit-risk assessment of Bydureon.”
The revelation comes at a particularly sensitive time for the US company, as it is currently a takeover target for a number of potential big pharma bidders, including AstraZeneca and Pfizer.
The Street publication first uncovered the story, and Amylin responded to the new by saying it was ‘committed to being transparent’.
Company spokeswoman Alice Izzo said: “Our interactions with regulatory agencies have been, and will continue to be, forthright and timely. Throughout the Bydureon review process, Amylin responded appropriately to requests for additional data.”
Andrew McConaghie
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