Last week, the FDA said it had received reports of six new cases of pancreatitis – including two deaths – associated with the diabetes drug Byetta. Today, Amylin and Eli Lilly said that they had reported four additional deaths to the agency as well, which the FDA hasn’t yet made public.
The companies, which co-market the drug, chose to disclose the additional information in order to “provide context” about each of the cases, according to Amylin President and Chief Executive Daniel Bradbury.
Byetta, co-marketed by the companies, already has a label reflecting its association with severe inflammation of the pancreas. But the FDA says it’s working on a stronger label for the drug that includes forms of pancreatitis that involve bleeding and cell death.
In the four cases brought forward by the companies today, it’s not clear whether the patients were taking Byetta at the time of deaths. And the deaths are “not directly attributable to pancreatitis in any way”, according to Orville Kolterman, Amylin’s senior vice president of R&D. For instance, one patient appeared to die from a relapse of leukemia two months after having pancreatitis. Also, patients with Type II diabetes have a greater risk of pancreatitis than healthy people to begin with, said Kolterman.
Analysts say the bigger picture issue is whether these safety concerns might affect the long-acting version of the medicine the companies are currently developing. The question “is whether the FDA, from a regulatory standpoint, will require longer term study of the long-acting version.
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