Lilly, Amylin Disclose More Cases of Byetta-Related Pancreatitis
Posted by Shirley S. Wang
ByettaLast 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, because the medical community appeared confused by the information last week, Amylin President and Chief Executive Daniel Bradbury told the Health Blog.
Another reason might be to reassure investors. 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. Both companies’ stock dipped following the news last week, though Amylin’s was particularly hard hit, plunging as much as 22% since the FDA announcement before recovering somewhat.
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”, Orville Kolterman, Amylin’s senior vice president of R&D, told us. 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, Barbara Ryan of Deutsche Bank told the Health Blog. “Rather than a short half-life, you’re going to have a longer term product. So if you get in trouble, it’s [in the body] for a longer period of time.”
surf's up......crikey
