FDA: Amylin Pharmaceuticals, Inc. Concealed Heart Safety Risks of Key Diabetes Drug
Amylin Pharmaceuticals(AMLN) concealed a study from the U.S. Food and Drug Administration that raised heart safety concerns about its diabetes drug Byetta and then hindered FDA access to the data when the agency discovered its existence, newly released FDA records show. Later, Amylin executives lied to investors by failing to disclose that this hidden Byetta heart-safety study played a key role in FDA rejecting the company's follow-on diabetes drug Bydureon, according to these same FDA records. The allegations that Amylin stonewalled FDA about the heart safety of its diabetes drugs and then misled investors about the issue come as the company is said to be seeking a Big Pharma buyer after turning down an unsolicited offer from Bristol-Myers Squibb(BMY).