Quoted from http://www.businessweek.com/news/2010-04-09/amylin-lilly-s-byetta-may-have-cancer-risk-fda-says-update1-.html
Amylin, Lilly’s Byetta May Have Cancer Risk, FDA SaysApril 09, 2010, 9:44 AM EDT
By Catherine Larkin
April 9 (Bloomberg) -- Amylin Pharmaceuticals Inc. and Eli Lilly & Co.’s diabetes drug Byetta may be giving a “false sense of security” to doctors and patients about potential cancer risks, a top U.S. drug reviewer said.
Data on intravenous dosing and an extended-release form of Byetta “seem to give a similar signal” as cancers seen in rodent studies of Novo Nordisk A/S’s competing Victoza, chemically known as liraglutide, said Curtis Rosebraugh, head of the Food and Drug Administration’s Office of Drug Evaluation II, in a Jan. 25 memo posted today on the agency’s Web site.
Novo Nordisk, of Bagsvaerd, Denmark, won FDA approval for Victoza in January after 10 months of delay because of safety concerns. The agency recommended against using the daily shot as an initial treatment for diabetes until additional studies are completed to assess a potential risk of thyroid tumors.
“Our internal data indicates that the preclinical findings are not unique to liraglutide but will probably extend to all” similar long-acting diabetes drugs, Rosebraugh said. “So to condemn liraglutide would be to condemn them all.”
Kindra Strupp, a spokeswoman for Indianapolis-based Lilly, didn’t return a phone call seeking comment. Anne Erickson, a spokeswoman for Amylin, didn’t immediately return a voice-mail message for comment.
The FDA delayed a decision on a proposed once-weekly version of Byetta on March 15 and asked for more information on manufacturing, labeling and a risk-management plan. No new studies were ordered.
Amylin, based in San Diego, fell 24 cents, or 1 percent, to $23.65 at 9:31 a.m. in Nasdaq Stock Market composite trading. Lilly rose 13 cents to $36.65 in New York Stock Exchange composite trading.
Almost 24 million Americans have diabetes, caused by a lack of insulin needed to convert blood sugar into energy, according to the National Institutes of Health. Most have the Type 2 form of the disease linked to older age, excess weight and physical inactivity.
Both Victoza and Byetta, now sold as a twice-daily shot, belong to a new class of diabetes medicines that imitate a hormone called GLP-1 to stimulate the pancreas to produce more insulin after meals.