Amylin Pharmaceuticals, the maker of Byetta, is coming under fire for allegedly hiding a study that revealed serious heart risks associated with the type 2 diabetes medication. According to a report from TheStreet.com, the U.S. Food & Drug Administration (FDA) claims the company concealed the Byetta heart study from the agency, and then tried to keep the FDA from getting its hands on the key data when the agency learned of its existence.
As we’ve reported previously, Byetta belongs to a drug class called glucagon-like peptide-1 mimetics, which lower blood sugar levels for diabetics by promoting the action of the hormone glucagon-like peptide 1 (GLP-1) in the gut. Byetta, administered via a twice-daily injection, was first approved in 2005 to be used in conjunction with other diabetes treatments. It was later approved as a stand-alone therapy for type 2 diabetes.
According to a January 2012 memo written Mary Parks, division director of the FDA unit responsible for regulating diabetes drugs, the approval of Amylin’s longer-acting Bydureon was “long and complicated process, partly because of “Amylin’s withholding of information on Byetta that FDA deemed to be important to its evaluation of the safety and effectiveness of Bydureon.” Byetta and Bydureon share the same active ingredient.
The memo states that the FDA only learned of concerning heart findings associated with Byetta when Canadian regulators alerted the agency to the study in question. Amylin then stalled when the FDA asked to see the research.
According to TheStreet, Amylin submitted Bydureon for approval in May 2009, but the FDA rejected the drug in 2010. In doing so, the agency cited “the completion of a risk management plan and resolution of some product quality issues as the only deficiencies needed to be remedied.” Upon then learning from Health Canada about the existence of the troubling Byetta study, the FDA asked for the data to be included in Amylin’s Bydureon resubmission. But when the application was resubmitted, the data were missing, Parks wrote. It turns out Amylin had instead submitted the study data separately as an addendum to the original Byetta regulatory file.
The FDA, however, still considered the Byetta data in its review of Amylin’s Bydureon resubmission. That October, the agency rejected Bydureon a second time, in part over the safety concerns raised by the Byetta heart safety study, according to TheStreet. The FDA then requested that the company conduct a new heart study, but Amylin balked and asked that it be considered after the agency had approved the Bydureon for sale.
The FDA did eventually approve Bydureon, but Amylin also hid the truth about the Byetta heart study from its investors. According to TheStreet, FDA records indicate Amylin failed failing to disclose that the Byetta heart-safety study played a key role in the FDA’s rejection of the drug.