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New Long-Acting Disbetes Drugs - Amylin, Lilly's Byetta May Have Cancer Risk, FDA Says
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By Catherine Larkin
April 9 (Bloomberg) -- Amylin Pharmaceuticals Inc. and Eli Lilly & Co.'s long-acting Byetta may be tied to increased cancer risk, a top U.S. regulator said, raising concerns that the experimental diabetes drug may need strict warnings.
Data on intravenous dosing and a once-weekly version of Byetta "seem to give a similar signal" as cancers seen in rodent studies of Novo Nordisk A/S's competing Victoza, said Curtis Rosebraugh, head of the Food and Drug Administration's Office of Drug Evaluation II, in a Jan. 25 memo posted on the agency's Web site. (see attached pdf of FDA memo)
Victoza was approved in January after 10 months of delay because of safety concerns. During that review, the FDA said thyroid tumors may be common with all extended-release diabetes drugs in a family of medicines known as GLP-1 analogs, a class that includes Byetta and Victoza. The new memo is the first indication that long-acting Byetta will carry the same boxed warning, the agency's strictest caution, as Victoza, said Phil Nadeau, an analyst at Cowen & Co. in New York.
"Our checks suggest that the black box is likely to dissuade some generalist physicians from adopting the long- acting GLP-1s, and therefore will make it somewhat harder for the class to achieve the growth assumed" by some investors, Nadeau said today in a note to clients.
Byetta, now sold as a twice-daily shot, had worldwide sales of $796.5 million last year, according to Lilly's annual report. The Indianapolis-based company sells the drug outside the U.S. and splits U.S. revenue with Amylin, of San Diego. Byetta is Amylin's biggest product.
Byetta FDA Delay
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 for the product, to be called Bydureon. Technology for the long-acting version was developed by Alkermes Inc., of Waltham, Massachusetts.
"A relationship between Bydureon and human thyroid cancer has not been established, but cannot be ruled out," said Kindra Strupp, Lilly spokeswoman, in an e-mail today. A statistically significant increase in thyroid cancers was seen in female rats given doses 25 times greater than people take, she said. Strupp said Amylin had referred calls for comment to Lilly.
Amylin fell 7 cents to $23.82 at 4 p.m. New York time in Nasdaq Stock Market composite trading, while Alkermes dropped 9 cents to $13.40. Lilly added 32 cents to $36.84 in New York Stock Exchange composite trading.
Novo Nordisk's Victoza, a daily shot chemically known as liraglutide, isn't recommended by the FDA as an initial treatment for diabetes. The FDA ordered the Bagsvaerd, Denmark- based company to conduct additional studies to assess a potential risk of thyroid tumors.
'Condemn Them All'
"Our internal data indicates that the preclinical findings are not unique to liraglutide but will probably extend to all" similar long-acting diabetes drugs, the FDA's Rosebraugh said in the memo included in Victoza's approval package. "So to condemn liraglutide would be to condemn them all."
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.
Victoza and Byetta belong to a class of diabetes medicines that imitate a hormone called GLP-1 to stimulate the pancreas to produce more insulin after meals.
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