This is not good news for Eli Lilly or its partner, Amylin Pharmaceuticals, which are counting on their once-weekly version of the Byetta diabetes treatment to become a much-needed blockbuster. A Jan. 25 memo written by an FDA official notes that data suggests the med appears to "give a similar signal" as cancers seen rat studies of Novo Nordisk's competing Victoza.
Victoza, you may recall, was approved in January after nearly a year's delay over safety concerns. At the time, the agency noted that thyroid tumors may be common with all extended-release diabetes drugs in a group of meds known as GLP-1 analogs, which includes Byetta and Victoza. Last month, the FDA delayed approving the new Byetta and sought more info on labeling and a risk-management plan, although new studies weren't required.
The memo (which you can read here) was written by Curtis Rosebraugh, who heads the FDA’s Office of Drug Evaluation II and Phil Nadeua, a Cowen & Co. analyst tells Bloomberg News this appears to be the first indication that the new version of Byetta will carry the same boxed warning as Victoza.
A Lilly spokeswoman wrote Bloomberg that a relationship between the new Byetta, to be called Bydureon, and human thyroid cancer hasn't been established, but can't be ruled out, and added that a statistically significant increase in thyroid cancers was seen in female rats given doses 25 times greater than people take.
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