Pharmaceutical Drug Litigation Updates

FDA Conducting Safety Review Of Certain Diabetes Drugs

Quoted from http://online.wsj.com/article/BT-CO-20130314-709260.html

FDA Conducting Safety Review Of Certain Diabetes Drugs

By Jennifer Corbett Dooren

• March 14, 2013, 11:46 a.m. ET

WASHINGTON--The U.S. Food and Drug Administration Thursday said it is reviewing information about a class of diabetes drugs that suggests they might cause pre-cancerous changes in the pancreas.

Such drugs involve newer types of Type 2 diabetes medicines that include Bristol-Myers Squibb Co.'s (BMY) Byetta, Bydureon and Onglyza; Novo Nordisk A/S's (NVO) Victoza; Merck & Co.'s (MRK) Januvia; and Eli Lilly & Co.'s (LLY) Tradjenta. The pancreas is a gland that produces several hormones and enzymes, including insulin.

The labels on the drugs currently warn of an increased risk of pancreatitis, or inflammation of the pancreas, but the suggestion of pre-cancerous changes in the pancreas is new. However, the FDA stressed that it hasn't concluded that the medicines "may cause or contribute to the development of pancreatic cancer."

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Newest Diabetes Drugs Linked to Higher Pancreatitis Risk

Novo Nordisk rejects diabetes drug Victoza complaint

Quoted from http://www.reuters.com/article/2012/04/20/us-novonordisk-victoza-idUSBRE83J0FZ20120420

Novo Nordisk rejects diabetes drug Victoza complaint

COPENHAGEN | Fri Apr 20, 2012 6:00am EDT

COPENHAGEN (Reuters) - Danish drugmaker Novo Nordisk rejected a consumer advocacy group's complaint about its big-selling diabetes drug Victoza as groundless and said it did not expect U.S. regulators to take any action.

Its shares initially dropped more than 2 percent in brisk trade on Friday after non-profit group Public Citizen asked the U.S. Food and Drug Administration (FDA) to withdraw approval of Victoza.

Novo Nordisk, the world's biggest producer of insulin used to treat diabetes, was the most-traded stock on the Copenhagen bourse, with more than 350 million Danish crowns ($61.8 million) worth changing hands.

Public Citizen said on Thursday that Victoza increases the risk of serious health problems such as thyroid cancer and kidney failure.

Novo Nordisk's Chief Science Officer Mads Krogsgaard Thomsen told Reuters on Friday that Public Citizen had referred to old data from studies on mice and rats which had no relevance to the use of Victoza in humans.

"We do not expect any consequences for Victoza from Public Citizen's petition," Thomsen said. "There is nothing in it."

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Safety and tolerability of glucagon-like peptide-1 receptor agonists in the treatment of type 2 diabetes

Quoted from http://dvd.sagepub.com/content/12/1/6.abstract

Safety and tolerability of glucagon-like peptide-1 receptor agonists in the treatment of type 2 diabetes

Abstract

 

Conventional pharmacotherapies for type 2 diabetes effectively lower blood glucose levels but are associated with side effects that preclude their optimal use or raise safety concerns. Novel treatments based on the endogenous hormone glucagon-like peptide-1 (GLP-1) may overcome some of these obstacles. The GLP-1 receptor agonists, exenatide and liraglutide, have a lower risk of hypoglycaemia than some conventional agents and can provide significant weight loss. Although they can cause gastrointestinal symptoms, effects are transient and can be reduced by gradual dose escalation. No cardiac safety issues have been reported and animal studies suggest that they may confer cardiovascular benefits. Pancreatitis has occurred among patients receiving GLP-1 receptor agonists, but it is unclear whether this is drug-related or due to the increased risk of pancreatitis in type 2 diabetes. Despite findings in rodents that GLP-1 receptor activation of thyroid C-cells results in calcitonin release and C-cell pathology, such effects have not been seen with long-term exposure in humans. Immunogenicity does not appear to be a safety concern. In summary, currently available data indicate that GLP-1 receptor agonists provide an effective and generally well tolerated therapeutic option for the management of type 2 diabetes.

Liraglutide-associated acute pancreatitis.

Quoted from http://highwire.stanford.edu/cgi/medline/pmid;22345417

Liraglutide-associated acute pancreatitis. E Knezevich, T Crnic, S Kershaw, and A Drincic Am. J. Health Syst. Pharm., March 1, 2012; 69(5): 386-9.
Purpose A case of acute pancreatitis associated with liraglutide is reported. Summary A 53-year-old African-American man (height, 185.4 cm; weight, 108.6 kg) with type 2 diabetes mellitus arrived at the emergency department (ED) with new-onset intolerable abdominal pain in the right upper quadrant and left upper quadrant that had appeared suddenly and lasted two to three hours. He had nausea but no vomiting, with tenderness in the epigastric region. In the ED, his serum amylase concentration was found to be extremely elevated (3,963 units/L), as was his serum lipase concentration (>15,000 units/L). In addition to type 2 diabetes, his medical history included hyperlipidemia, hypertension, peripheral neuropathy, erectile dysfunction, and obesity. His home medications included aspirin 81 mg orally daily, metformin 1000 mg orally every morning and 1500 mg every evening, simvastatin 80 mg orally daily at bedtime, tadalafil 20 mg orally as needed, glimepiride 4 mg orally twice daily, and liraglutide 1.2 mg subcutaneously daily. Two months before his arrival to the ED, the patient's dosage of liraglutide was increased from 0.6 to 1.2 mg subcutaneously daily. Radiographic data were obtained, and acute pancreatitis was diagnosed. Liraglutide was discontinued indefinitely after ruling out elevated triglycerides as the cause of pancreatitis. The patient was initiated on standard therapy for acute pancreatitis and discharged eight days later with complete resolution of symptoms and normal laboratory test values. Conclusion A 53-year-old man with type 2 diabetes mellitus developed a probable case of liraglutide-induced acute pancreatitis after receiving the drug for approximately two months.

Lilly, Novo Diabetes Drugs Drew Renewed Scrutiny On Possible Cancer Links

Quoted from http://www.bloomberg.com/news/2011-09-12/lilly-novo-diabetes-drugs-drew-renewed-scrutiny-on-possible-cancer-links.html

Lilly, Novo Diabetes Drugs Drew Renewed Scrutiny On Possible Cancer Links

By Albertina Torsoli - Sep 13, 2011 8:56 AM ET

Amylin Pharmaceuticals Inc. (AMLN) and Eli Lilly & Co. (LLY)’s Byetta medicine and Novo Nordisk A/S’s Victoza face scrutiny after some researchers warned that prolonged use of the insulin-raising treatments may make diabetics more vulnerable to cancers.

A debate on the potential dangers of GLP-1 therapies, the class of drugs to which Byetta and Victoza belong, will be a highlight of the European Association for the Study of Diabetes conference in Lisbon this week. A review of a database of side effects showed patients taking Byetta and a Merck & Co. drug had a sixfold increased chance of pancreatitis, which in turn raises the risk of tumors, researchers led by Robert Elashoff of the University of California at Los Angeles said this year.

The manufacturers say the treatments are safe and there’s no evidence of increased cancer risk. Sales of GLP-1 analogues, which mimic a hormone called GLP-1 to stimulate natural insulin production in diabetics, are increasing as doctors seek alternatives to older drugs for a disease that affects 366 million people worldwide, according to a new estimate today from the International Diabetes Federation.

“It’s a very tricky story,” Viktor Joergens, executive director of the EASD, said in a telephone interview. “You probably need decades and incredible numbers of people to study things like that. It will be a very interesting debate particularly because these drugs are now widely prescribed.”

Regulators already have taken note of possible links between the new classes of diabetes drugs and pancreatitis and thyroid tumors. Still, the renewed debate may prompt authorities to seek additional safety data before approving new GLP-1 drugs, Ele Ferrannini of the University of Pisa School of Medicine said in a telephone interview.

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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.