March 25 (Reuters) - Eli Lilly and Co :
* Boehringer ingelheim and Eli Lilly and Company submit new drug application to
FDA for Empagliflozin, an investigational type 2 diabetes treatment
* Source text * Further company coverage
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* Studying unconfirmed findings from researchers
* Says has asked for samples of pancreatic tissue
* Says agency has not reached new conclusions on drugs
* Suggests patients remain on therapies
(Adds details on Victoza, drug class, diabetes, updates share prices)
By Ransdell Pierson
March 14 (Reuters) - The U.S. Food and Drug Administration is studying unconfirmed reports that a widely used class of diabetes drugs, which includes Merck & Co's
Januvia, may cause inflammation of the pancreas and pre-cancerous changes to the pancreas.
The agency, in a notice on its website on Thursday, said this is the first time it has communicated potential pre-cancerous links to the medicines, known as incretin mimetics.
The drugs for type 2 diabetes also include Victoza from Danish drugmaker Novo Nordisk
and Onglyza from Bristol-Myers Squibb Co and AstraZeneca Plc .
Patients should continue taking their medicines as directed until speaking with healthcare professionals, the agency said. The FDA said it is investigating findings from academic researchers that highlighted the potential risk.
"These findings were based on examination of a small number of pancreatic tissue specimens taken from patients after they died from unspecified causes," the agency said.
The FDA has asked the researchers to explain how they collected and studied the specimens and to provide tissue samples so the agency can further assess any possible risks.
In the meantime, the FDA said it has not reached any new conclusions about safety risks of the class of drugs.
The agency noted it has previously warned the public about acute pancreatitis, including fatal and nonfatal cases, seen with the medicines. Package insert labels for the class of drugs already warn about risk of the potentially dangerous inflammation.
"It's too early to tell, but we'll keep an eye on it," Edward Jones analyst Judson Clark said, when asked about the significance of the potential safety issues in Thursday's FDA advisory.
But Clark said he did not expect any immediate changes in prescribing habits for the drugs because the pancreatitis risk is already noted on the drug labels.
The class of medicines, which mimic a natural hormone called incretin, prompt the pancreas to release insulin when blood sugar is rising. They are approved to treat type 2 diabetes, the most common form of diabetes which usually develops in adulthood and is closely linked to obesity.
Merck's Januvia and its related drug, Janumet, had combined sales last year of almost $6 billion, making them by far the company's biggest product franchise. Onglyza and a related drug called Kombiglyze had sales last year of $709 million.
Shares of Merck were down 1.1 percent at $44.08, while Bristol-Myers shares were down 0.8 percent at $38.18 on Thursday afternoon on the New York Stock Exchange. Shares of AstraZeneca were up 1 percent at $46.31, also on the NYSE. Novo Nordisk shares closed down 1 percent in Copenhagen.
(Reporting by Ransdell Pierson in New York; Editing by Sofina Mirza-Reid and Matthew Lewis)
((ransdell.pierson@thomsonreuters.com)(646 223 6030)(Reuters Messaging: ransdell.pierson.thomsonreuters.com@reuters.net))
Keywords: DIABETES PANCREAS/FDA
* Studying unconfirmed findings from researchers
* Says has asked for samples of pancreatic tissue
* Says agency has not reached new conclusions on drugs
* Suggests patients remain on therapies
(Adds details on Victoza, drug class, diabetes, updates share prices)
By Ransdell Pierson
March 14 (Reuters) - The U.S. Food and Drug Administration is studying unconfirmed reports that a widely used class of diabetes drugs, which includes Merck & Co's
Januvia, may cause inflammation of the pancreas and pre-cancerous changes to the pancreas.
The agency, in a notice on its website on Thursday, said this is the first time it has communicated potential pre-cancerous links to the medicines, known as incretin mimetics.
The drugs for type 2 diabetes also include Victoza from Danish drugmaker Novo Nordisk
and Onglyza from Bristol-Myers Squibb Co and AstraZeneca Plc .
Patients should continue taking their medicines as directed until speaking with healthcare professionals, the agency said. The FDA said it is investigating findings from academic researchers that highlighted the potential risk.
"These findings were based on examination of a small number of pancreatic tissue specimens taken from patients after they died from unspecified causes," the agency said.
The FDA has asked the researchers to explain how they collected and studied the specimens and to provide tissue samples so the agency can further assess any possible risks.
In the meantime, the FDA said it has not reached any new conclusions about safety risks of the class of drugs.
The agency noted it has previously warned the public about acute pancreatitis, including fatal and nonfatal cases, seen with the medicines. Package insert labels for the class of drugs already warn about risk of the potentially dangerous inflammation.
"It's too early to tell, but we'll keep an eye on it," Edward Jones analyst Judson Clark said, when asked about the significance of the potential safety issues in Thursday's FDA advisory.
But Clark said he did not expect any immediate changes in prescribing habits for the drugs because the pancreatitis risk is already noted on the drug labels.
The class of medicines, which mimic a natural hormone called incretin, prompt the pancreas to release insulin when blood sugar is rising. They are approved to treat type 2 diabetes, the most common form of diabetes which usually develops in adulthood and is closely linked to obesity.
Merck's Januvia and its related drug, Janumet, had combined sales last year of almost $6 billion, making them by far the company's biggest product franchise. Onglyza and a related drug called Kombiglyze had sales last year of $709 million.
Shares of Merck were down 1.1 percent at $44.08, while Bristol-Myers shares were down 0.8 percent at $38.18 on Thursday afternoon on the New York Stock Exchange. Shares of AstraZeneca were up 1 percent at $46.31, also on the NYSE. Novo Nordisk shares closed down 1 percent in Copenhagen.
(Reporting by Ransdell Pierson in New York; Editing by Sofina Mirza-Reid and Matthew Lewis)
((ransdell.pierson@thomsonreuters.com)(646 223 6030)(Reuters Messaging: ransdell.pierson.thomsonreuters.com@reuters.net))
Keywords: DIABETES PANCREAS/FDA
The reality of America’s obesity and diabetes epidemics and their resulting effects on national health care costs have been well-established — and on Thursday, a new report revealed that the public health crisis has gotten even worse in the last decade.
According to the report by the American Diabetes Association (ADA), direct and indirect health care costs associated with diabetes rose from $174 billion in 2007 to $245 billion in 2012 — an increase of 41 percent over 5 years. Only a little bit of that can be attributable to general medical inflation, which has actually been slowing down in the last couple of years. The sheer scope of the increase indicates that more and more Americans are falling prey to the disease — and it’s taking a clear toll on U.S. health care spending:
“As the number of people with diabetes grows, so does the economic burden it places on this country,” [said ADA's Chief Scientific & Medical Officer, Robert Ratner, in a statement.]
The study finds that medical expenditure for people with diabetes is about 2.3 times higher than for people who don’t have the disease and that the main driver of the increased overall financial burden on the country is the rise in proportion of the population that has the disease.
“The cost of diabetes is rising at a rate higher than overall medical costs with more than one in 10 health care dollars in the country being spent directly on diabetes and its complications, and more than one in five health care dollars in the US going to the care of people with diagnosed diabetes,” says Ratner.
Diabetes and obesity-related illnesses tend to disproportionately affect populations that are also on government-subsidized health programs — especially low-income Americans — and made up anywhere between 10 and 12 percent of all health insurance spending back in 2006. Considering the new report’s findings, that number has probably ballooned further. The study found that 64 percent of diabetes-related care, specifically, was funded by Medicare, Medicaid, and military health care programs.
NEW YORK -- French drugmaker Sanofi said Monday the Food and Drug Administration is starting a review of its once-a-day diabetes treatment lixisenatide.
Lixisenatide is a treatment for type 2 diabetes in adults. It works by increasing the body's insulin production and is part of a class of drugs called GLP-1 agonists. Other diabetes drugs in that group include Bristol-Myers Squibb Co.'s Byetta and Bydureon.
European Union regulators approved lixisenatide Feb. 1. Sanofi said it plans to start selling the drug late in the first quarter under the name Lyxumia. It has not chosen a U.S. brand name for lixisenatide.
U.S. shares of Sanofi rose $1.38, or 2.9 percent, to $49.40 in morning trading.
Sanofi's biggest-selling product is the diabetes drug Lantus. Sales of Lantus rose 23 percent to $6.55 billion in 2012, and Sanofi's total revenue from diabetes drugs grew 17 percent to $7.64 billion in 2012.
NEW YORK -- Shares of Furiex Pharmaceuticals Inc. surged Monday after regulators approved three new diabetes drugs that Japanese drugmaker Takeda developed with help from Furiex.
THE SPARK: On Friday, Takeda said the Food and Drug Administration approved the type 2 diabetes drug Nesina and the combination drugs Oseni and Kazano. Furiex, which teams up with drug companies to speed clinical development programs, said it will receive $25 million from Takeda as a result of the approval. It will also get royalties on sales of the drugs.
Nesina, or alogliptin, is designed to treat insufficient levels of insulin. The other two drugs also contain alogliptin, pairing it with other drugs in a single pill. Oseni combines the drug with the main ingredient in the diabetes medication Actos, an older drug made by Takeda that treats resistance to insulin. Kazano combines alogliptin and metformin, which has been used to treat diabetes for decades.
THE BIG PICTURE: Japanese regulators approved Nesina in 2010 and Oseni in 2011, and Furiex gets royalty payments on sales of those products. The Morrisville, N.C., company also has the rights to the premature ejaculation treatment Priligy, which is marketed in some countries by its partner Menarini Group.
Furiex reported a total of $5.6 million in royalty revenue in the third quarter.
Furiex is also studying treatments for irritable bowel syndrome and other diabetes drugs.
THE ANALYSIS: Canaccord Genuity analyst Randall Stanicky started covering Furiex shares with a "Buy" rating and a price target of $45 per share. He said the company should get a steady flow of cash in the form of royalty payments, adding that the Takeda diabetes drugs should be approved in Europe in the second half of the year. Stanicky said investors may be overlooking the value of Furiex's experimental drugs.
SHARE ACTION: Furiex shares rose $11.14, or 52.4 percent, to $32.38 in afternoon trading. Earlier the stock reached an all-time high of $32.97. The company completed its IPO in May 2010.
WASHINGTON -- The Food and Drug Administration on Friday approved three new formulations of a Takeda Pharmaceuticals Co. Ltd. diabetes drug designed to help patients control their blood sugar.
The common ingredient in all three drugs is a new compound called alogliptin, which stimulates the release of insulin, a hormone that controls blood-sugar levels. The FDA approved the drug in stand-alone form under the brand-name Nesina. The drug will also be sold in combination with metformin, under the name Kazano, and with pioglitazone, as Oseni. Metformin is a diabetes drug that has been used for decades. Pioglitazone is a newer diabetes drug sold by Takeda as Actos.
All three new drugs were approved for patients with type 2 diabetes, the most common form of the disease that affects about 24 million Americans. People with the disease have excessive levels of sugar in their blood, which can lead to heart attacks, kidney problems, blindness and other serious complications.
The FDA created tougher cardiovascular-safety standards for diabetes drugs in December 2008 after concerns were raised about certain treatments such Avandia, which was found to increase the risk of heart attacks.
Last year the patent on Takeda's best-selling diabetes drug Actos expired, allowing generic drugmakers to market cheaper versions. Nesina gives the company a new exclusive medicine in the diabetes market.
* FDA panel votes 10-5 in favor of canagliflozin approval
* Panel members would like longer-term follow-up on heart risk
* Drug is first in new class of treatments for Type 2 diabetes
(Updates with details from panel discussion)
Jan 10 (Reuters) - A panel of advisers to the U.S. Food and Drug Administration recommended the agency approve an experimental new treatment for diabetes developed by Johnson & Johnson, potentially making it the first drug of its type to be approved in the United States.
The FDA's Endocrinologic and Metabolic Drug Advisory Committee voted 10-5 on Thursday to recommend the agency approve the drug, canagliflozin, for Type 2 diabetes, saying that it proved effective at lowering blood sugar in patients with diabetes, though some panelists had lingering concerns about its potential to cause cardiovascular problems and recommended longer term follow-up.
Canagliflozin, which will be sold under the brand name Invokana, is a member of a new class of diabetes drugs known as sodium-glucose co-transporter-2 (SGLT2) inhibitors which lower blood sugar by blocking reabsorbtion of glucose by the kidney and increasing the excretion of glucose in urine.
In its discussion, the panel weighed the relative risks and benefits of canagliflozin, especially in relation to any potential it might have to increase the risk of heart attack or stroke.
A clinical trial of patients at especially high risk of cardiovascular disease showed that within the first 30 days, 13 patients taking canagliflozin suffered a major cardiovascular event compared with just one patient taking a placebo. After that the imbalance was reversed. The drug also caused a slight increase in unhealthy LDL cholesterol.
The majority of panelists felt the overall risk benefit profile was acceptable but that longer-term data will be needed to fully assess the impact on patients of the higher LDL levels. The y were unable to determine conclusively that the imbalance in cardiovascular events seen in the first 30 days was a statistical anomaly.
Diabetes is a condition that affects the body's ability to metabolize glucose and is often caused by obesity. Left untreated, the disease can cause nerve disease leading to amputation, as well as kidney disease and blindness. It affects roughly 26 million people in the United States.
The panel also weighed the relative benefit of the drug for patients with impaired kidney function -- a common feature of patients with diabetes. They concluded that since the drug is less effective in patients whose kidney function is damaged, the risks may well outweigh the benefits in those patients.
Jeff Jonas, an analyst with Gabelli & Co, who estimates the drug will generate at least a billion dollars in annual sales for J&J, said he believes the FDA will approve the drug.
"It clearly works, and the side effects were not a major issue. If a patient has impaired kidneys, I think the FDA will say no, don't use it."
Damien Conover, an analyst at Morningstar, believes the drug could generate peak annual sales of more than $2 billion.
The vote in favor of canagliflozin follows the agency's rejection last January of a similar drug made by Bristol-Myers Squibb Co and AstraZeneca Plc. That drug was subsequently approved in Europe, however, under the brand name Forxiga. European regulators concluded that concerns cited by the FDA about a potential increased risk of cancer or liver injury were addressed by warnings in the drug's product label.
A recent report by market research firm Decision Resources estimated that the market for Type 2 diabetes drugs will nearly double over the next decade, increasing from $26 billion in 2011 to nearly $50 billion in 2021 in the United States, Japan and the main markets of Europe.
The FDA is set to rule on whether to approve the drug by March 29th. The agency is not required to follow the advice of its advisory panel but typically does so.
(Reporting By Toni Clarke in Boston; additional reporting by Ransdell Pierson and Bill Berkrot in New York; editing by Carol Bishopric)
