Did Amylin hide the risks of Byetta?

Newly released documents suggest that Amylin hid a study from the U.S. Food & Drug Administration (FDA) which would have raised heart safety concerns about its blockbuster drug Byetta.

Newly released documents suggest that Amylin hid a study from the U.S. Food & Drug Administration (FDA) which would have raised heart safety concerns  about its blockbuster drug Byetta.   Complicating matters, company executives did not tell its shareholders that this study contributed to the FDA rejecting Amylin’s diabetes drug Bydureon.

According to a January 2012 memo by FDA division director Mary Parks, the FDA review of Bydureon was obstructed  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”.

The FDA rejected the Bydureon submission in March 2010, responding that prior to approval Amylin would need to resolve some product quality and risk management issues.  However, shortly after the initial rejection, Canadian regulators told the FDA about a study conducted by the company two years earlier, which suggested Byetta significantly raised heart safety concerns for Canadian regulators.  But this study and its data never reached the FDA.

As Mary Parks writes, “more importantly, FDA was not informed by Amylin that Health Canada considered several findings from tQT study concerning enough such that approval was delayed in Canada because agreement on product labeling could not be reached”.

Upon learning of the existence of the hidden study, the FDA asked Amylin to produce the data in the Bydureon resubmission.  But Amylin resubmitted the application again without the hidden data.  Instead, Amylin submitted the study as an addendum to the original application.  In October 2010, the FDA rejected Bydureon for a second time.

Following this rejection, Amylin’s stock were almost halved as investors, also kept in the dark about the troubling data and its implications, were caught off guard.

In early 2012, the FDA finally granted approval for Bydureon.  However, the FDA is currently requiring Amylin to conduct a clinical trial  (already underway) to assess whether Bydureon increases the risk of heart attacks and other cardiovascular problems, as well as look at whether the drug increases the risk for thyroid cancer, pancreatitis and other health problems.

Currently, the law firm of Slater Slater Schulman LLP is investigating the alleged links between Byetta and pancreatic cancer which surfaced as part of a UCLA study which found Byetta may raise the risk of pancreatic cancer almost threefold.  If you or someone you love has suffered from pancreatic cancer after using Byetta, you can have a free consultation with an attorney at Slater Slater Schulman LLP by filling out the form on this page or calling (800) 251-6990.

Sources: http://www.thestreet.com/print/story/11595037.htmlhttp://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/022200Orig1s000SumR.pdfhttp://www.nytimes.com/2012/01/28/health/bydureon-a-diabetes-drug-from-amylin-wins-fda-approval.html


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