Pharmaceutical Drug Litigation Updates

Drugmakers to cooperate in safety review of diabetes drugs

Quoted from http://www.reuters.com/article/2013/06/12/us-diabetes-safety-idUSBRE95B17J20130612

Drugmakers to cooperate in safety review of diabetes drugs

By Bill Berkrot

NEW YORK | Wed Jun 12, 2013 5:14pm EDT

NEW YORK (Reuters) - Global drugmakers said on Wednesday they would cooperate with an independent review to address concerns of a potential link between widely used diabetes medicines and pancreatic cancer and other safety problems.

The American Diabetes Association (ADA) this week called for a new evaluation of clinical data on drugs used to control blood sugar for patients with type 2 diabetes. They include Merck & Co's $4 billion a year Januvia franchise, Novo Nordisk's Victoza, and Byetta and Onglyza from Bristol-Myers Squibb Co and AstraZeneca Plc, among others.

"People who are taking these medications, or who may consider taking them, should have the benefit of all that is currently known about their risks and advantages in order to make the best possible decisions about their treatment," Dr. Robert Ratner, ADA's chief scientific and medical officer, said in a statement.

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Merck Joins Novo to Reassure FDA of Diabetes Drug Safety

Quoted from http://www.bloomberg.com/news/2013-06-12/merck-joins-novo-to-reassure-safetynof-diabetes-drugs.html

Merck Joins Novo to Reassure FDA of Diabetes Drug Safety

By Anna Edney - Jun 12, 2013 10:57 AM ET

Merck & Co. (MRK), Novo Nordisk A/S (NOVOB) and other makers of popular treatments for diabetes may be asked to collect more data on a potential cancer link even as they try to reassure U.S. regulators this week of the drugs’ safety.

The Food and Drug Administration said it’s considering setting up a study, either through the agency or the companies, that looks deeper into whether medicines for Type 2 diabetes, including Merck’s Januvia and Bristol Myers-Squibb Co.’s Byetta, cause pancreatic cell growth that could turn cancerous. One option is a large clinical trial designed to show patterns of adverse events, said Morgan Liscinsky, an FDA spokeswoman.

A debate swirled in the medical community in March with talk of unpublished findings that the FDA said may show pre-cancerous cellular changes in diabetics taking drugs called incretin mimetics. The FDA is reviewing the data and scientists from the agency and the companies are gathering today at the National Institutes of Health to sort it out.

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Doctor’s Doubts Imperil Lucrative Diabetes Drugs

Quoted from http://www.nytimes.com/2013/05/31/business/a-doctor-raises-questions-about-a-diabetes-drug.html

A Lone Voice Raises Alarms on Lucrative Diabetes Drugs

 

By ANDREW POLLACK

Published: May 30, 2013

LOS ANGELES — Dr. Peter C. Butler initially declined a request by the drug maker Merck to test whether its new diabetes drug, Januvia, could help stave off the disease in rats.

I said, I’m not interested in your money, go away,” Dr. Butler recalled.

Merck no doubt now wishes it had. When Dr. Butler finally agreed to do the study, he found worrisome changes in the pancreases of the rats that could lead to pancreatic cancer. The discovery, in early 2008, turned Dr. Butler into a crusader whose follow-up studies now threaten the future of not only Januvia but all the drugs in its class, which have sales of more than $9 billion annually and are used by hundreds of thousands of people with Type 2 diabetes.

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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

Newest Diabetes Drugs Linked to Higher Pancreatitis Risk

Quoted from http://health.usnews.com/health-news/news/articles/2013/02/25/newest-diabetes-drugs-linked-to-higher-pancreatitis-risk

Newest Diabetes Drugs Linked to Higher Pancreatitis Risk

Patients on Januvia, Byetta twice as likely to develop condition, study says

February 25, 2013

MONDAY, Feb. 25 (HealthDay News) -- Diabetes patients who take the latest class of drugs to control blood sugar levels are twice as likely to develop pancreatitis as those who take other medications to control blood sugar, according to a new study.

The drugs Januvia (sitagliptin) and Byetta (exenatide) are glucagon-like peptide-1-based (GLP-1) therapies, which are used by millions of Americans with diabetes.

Pancreatitis is inflammation of the pancreas, the organ that releases hormones such as insulin and glucagon, as well as enzymes that help digest food. Pancreatitis is a painful condition that can be dangerous if left untreated. People with diabetes are already at higher risk for pancreatitis because of the role the pancreas plays in the condition.

In this study, researchers from Johns Hopkins University in Baltimore compared nearly 1,300 type 2 diabetes patients who took one of the GLP-1 drugs with the same number of type 2 diabetes patients who took other medications. Those who took the GLP-1 drugs were twice as likely to be hospitalized with acute pancreatitis within 60 days of first taking the drugs than the other group of patients.

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Merck, Bristol Diabetes Drugs Linked to Pancreatitis Risk - Bloomberg

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.

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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No pancreatitis risk seen in Byetta, Januvia drugs-study

Quoted from http://blogs.reuters.com/lewis-krauskopf/2010/06/27/no-pancreatitis-risk-seen-in-byetta-januvia-drugs-study/

No pancreatitis risk seen in Byetta, Januvia drugs-study

Jun 27, 2010 12:29 EDT

NEW YORK, June 27 (Reuters) – Two widely used diabetes
medicines, Januvia and Byetta, pose no additional risk for
cases of inflamed pancreas compared with other diabetes drugs,
according to an analysis of medical claims data released on
Sunday.

The study could boost Januvia, sold by Merck & Co (MRK.N: Quote, Profile, Research),
and Byetta, from Amylin Pharmaceuticals Inc (AMLN.O: Quote, Profile, Research) and Eli
Lilly & Co (LLY.N: Quote, Profile, Research). Both drugs are important products for the
companies but have faced concerns that they are linked to acute
pancreatitis, which can be life threatening.

The study also found that diabetics generally are at
increased risk of acute pancreatitis, compared with
non-diabetics, which the study’s author said confirmed previous
research, although the risk remains very low.

The analysis was conducted by pharmacy benefit manager
Medco Health Solutions (MHS.N: Quote, Profile, Research), in association with the
University of Texas Southwestern Medical School. Medco, which
manages benefits and tries to lower drug bills for employers,
insurers and other clients, is conducting studies using its
vast medical claims database as it seeks to raise its profile
as a clinical company.

Dr. Merri Pendergrass, who conducted the study,
acknowledged that it was an observational study of data, as
opposed to the gold standard of a randomized clinical trial.

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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.

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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