Drug Safety Developments

Amylin, Lilly’s Byetta May Have Cancer Risk, FDA Says

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 Says

April 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.

Byetta Delayed

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.

Amylin Falls as Analyst Says FDA Wants Byetta Study

Quoted from http://www.bloomberg.com/apps/news?pid=20601103&sid=a3D7cQXuMZXk

Amylin Falls as Analyst Says FDA Wants Byetta Study

By Rob Waters

Dec. 23 (Bloomberg) -- Amylin Pharmaceuticals Inc. fell the most in more than eight months in Nasdaq trading after a Citigroup analyst said U.S. drug regulators are requiring more studies of the diabetes drug Byetta to assess its safety.

San Diego-based Amylin and Indianapolis-based Eli Lilly & Co., which co-market the drug, announced Oct. 30 that the Food and Drug Administration had cleared the drug for use as standalone therapy for Type 2 diabetics and that prescribing information would warn about the risk of pancreatitis, an inflamed pancreas, in patients with severe kidney disease. That statement didn’t say the FDA wanted more studies.

Citigroup analyst Yaron Werber said today in a note to investors that he had obtained a copy of the FDA’s approval letter and that the agency was requiring animal and human studies aimed at clarifying the risk of pancreatitis posed by the drug. A statement e-mailed by Lilly and Amylin today said most of the requested studies are under way and have shown no increased risk of pancreatitis in patients taking Byetta.

“The FDA considers post-marketing reports of acute pancreatitis (fatal and non-fatal hemorrhagic or necrotizing pancreatitis), acute renal failure and thyroid neoplasms as ‘new safety information’ and is requiring Amylin to conduct additional studies,” Werber said in his note.

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Amylin, Lilly’s Byetta Gets Stronger Safety Warning

Quoted from http://www.bloomberg.com/apps/news?pid=newsarchive&sid=ao.MFuy7uz20

Amylin, Lilly’s Byetta Gets Stronger Safety Warning

By David Olmos and Rob Waters

Oct. 30 (Bloomberg) -- Amylin Pharmaceuticals Inc. and Eli Lilly & Co. said safety warnings were strengthened for their diabetes drug Byetta relating to the risks of pancreatitis and the medicine’s use by patients with severe kidney disease.

Patients with “severe kidney problems” shouldn’t take Byetta and the treatment should be “used with caution” in people who have had a kidney transplant, San Diego-based Amylin and Indianapolis-based Lilly said today in a statement. The companies also said U.S. regulators approved the use of the drug as a stand-alone medication for adults with Type 2 diabetes.

Six patients taking Byetta died in August 2008 from pancreatitis, an inflamed pancreas. A safety alert was issued by the Food and Drug Administration though Amylin said no evidence directly linked the drug to the deaths. The revised language reflects the concerns raised by the FDA a year ago, Ken Wilhelm, Amylin’s medical director, said today in a telephone interview.

“The data still do not support a causal relationship between Byetta and pancreatitis,” Wilhelm said. “That said, it’s an important safety issue and we continue to work diligently to explore the potential relationship.”

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