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12:00 AM
 | 
Sep 01, 2008
 |  BioCentury  |  Regulation

Byetta’s benefit of doubt

Clinicians are skeptical that there is any causal relationship between Byetta exenatide and six new cases of acute pancreatitis, including two deaths, announced by FDAlate last month. They also said they didn’t plan to change their prescribing habits as a result of the report. Nevertheless, shares of the drug’s sponsor, Amylin Pharmaceuticals Inc., took a beating as the company disclosed four other deaths last week.

The reactions illustrated the disparate views of the clinical community and investors to FDA announcements about emerging safety signals. Such announcements have become increasingly common as the agency interprets public demands and mandates of the FDA Amendments Act (FDAAA) to require dissemination of safety data, including in cases where causality has not been definitely determined.

The six cases of hemorrhagic or necrotizing pancreatitis occurred in patients with Type II diabetes taking Byetta from Amylin and partner Eli Lilly and Co. Of the two patients who died, one was morbidly obese and had extensive gallstone disease at autopsy. The other had stopped taking Byetta “some months” before being hospitalized for pancreatitis, said Amylin SVP of R&D Orville Kolterman.

In a post-market conference call Tuesday, the companies reported four additional deaths in patients taking Byetta who at some point had experienced pancreatitis. Kolterman said those deaths “did not appear directly attributable to pancreatitis.” Two patients died from complications following gallbladder surgery, one died of a...

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