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Diabetes and Byetta Article Archives

March 2014

FDA Backtracks Over GLP-1s' Effects on Pancreas

The U.S. Food and Drug Administration reports that its review of various animal and human studies does not show a link between GLP-1 drugs used to treat type 2 diabetes and pancreatic maladies, including acute pancreatitis and pancreatic cancer.

comments 0 comments - Posted Mar 4, 2014

February 2014

Weekly Type 2 Drug to Be Delivered Via Needle Patch

A recent agreement between Zosano Pharma, Inc. and Novo Nordisk could lead to the introduction of a once-weekly drug for type 2s that is administered via a micro-needle patch system.

comments 0 comments - Posted Feb 24, 2014

October 2013

First-World Type 2 Drug Market to Reach $47 Billion by 2022

A Massachusetts-based research firm concludes that the first-world market for type 2 drugs and treatments will increase from $27 billion in sales in 2012 to $47 billion in 2022.

comments 0 comments - Posted Oct 18, 2013

Byetta for Type 1s? It Could Be Possible

Many people with type 2 diabetes are familiar with Byetta, a drug that helps raise their insulin levels. But a new study in the journal Diabetes Care suggests that the drug, known generically as exenatide, might have a role to play for people with type 1 diabetes as well.

comments 0 comments - Posted Oct 3, 2013

June 2013

My Life as a Guinea Pig

About five years ago during a visit to a local endocrinologist, he asked if I might be interested in participating in a Phase 3 study of a new type 2 drug. It didn't take long for me to say yes, especially once he explained how being a study subject worked.

comments 2 comments - Posted Jun 10, 2013

January 2013

Type 2: Oramed Sends Oral Insulin Test Request to FDA

Israel-based Oramed announced that it has sent an application to the Food and Drug Administration for permission to enter Phase 2 trials of its oral insulin product. The company has been working on developing a means of delivering insulin orally, which would allow people with diabetes to avoid having to inject themselves with the hormone.

comments 1 comment - Posted Jan 16, 2013

November 2012

Lilly Says Its New Injectible Outperforms Three Popular Diabetes Drugs

Good news for Eli Lilly & Co., as well as for type 2s who appreciate the addition of new drugs to treat their condition: Lilly says its once-weekly injectible drug, dulaglutide, has outperformed three other widely taken diabetes drugs in three just-concluded Phase III studies.

comments 0 comments - Posted Nov 20, 2012

Lilly Says Its New Injectible Outperforms 3 Popular Diabetes Drugs

Good news for Eli Lilly & Co., as well as for type 2s who appreciate the addition of new drugs to treat their condition: Lilly says its once-weekly injectible drug, dulaglutide, has outperformed three other widely taken diabetes drugs in three just-concluded Phase III studies.

comments 0 comments - Posted Nov 5, 2012

March 2012

Am I Doing the Right Thing?

Readers occasionally ask us for advice about drugs they are taking. When they do, we refer their questions to a medical professional. In the question below, a Florida reader expresses concerns about the interaction of her diabetes drug with the medicines she takes for asthma.

comments 0 comments - Posted Mar 29, 2012

February 2012

An Update on Bydureon

You've heard of the blockbuster drug Byetta, a daily injection for type 2 diabetes? Byetta's sister product, Bydureon, which is injected just once a week, has just been approved by the FDA and is available in pharmacies.

comments 14 comments - Posted Feb 17, 2012

FDA Gives Long-Awaited Nod to Amylin’s Bydureon

After several years of delays and setbacks, Amylin Pharmaceuticals has received FDA approval to begin US marketing of BydureonTM. The first once-a-week type 2 therapy to be offered in the US market, Bydureon is expected to be available by February. Amylin says that its wholesale price will be about $4,200 a year.

comments 2 comments - Posted Feb 3, 2012

May 2011

Sanofi Says Late-Stage Trial of Type 2 Drug a Success

French drug maker Sanofi-aventis says that results from a Phase III trial of its experimental type 2 diabetes drug lixisenatide show that the drug successfully lowered patients' blood glucose levels and body weight, but did not increase the risk of hypoglycemia.

comments 0 comments - Posted May 23, 2011

July 2010

Study Says Byetta and Januvia Do Not Pose Extra Risk for Pancreatitis

A study released in late June has brought some welcome news to the makers of Byetta and Januvia: Users of the two diabetes drugs run no greater risk of developing pancreatitis than people with diabetes who take other drugs. In fact, both drugs seem to put users at slightly less risk for the condition.

comments 0 comments - Posted Jul 8, 2010

March 2010

FDA Hedges Approval of Long-Acting Byetta, Asks Amylin for More Information

The U.S. Food and Drug Administration has withheld approval of Bydureon, the once-weekly version of the popular type 2 diabetes drug Byetta.  The agency has asked its manufacturer, Amylin, for more information regarding Bydureon's manufacture, labeling, and risk management plan. It did not, however, request further information on tests of the drug itself-an indication that the agency probably intends to grant marketing permission once it has dotted all the i's and crossed all the t's involved in the approval process.

comments 0 comments - Posted Mar 29, 2010

Amylin Hopes to Begin U.S. Sales of Long-Acting Byetta Early This Year

Amylin Pharmaceuticals has announced that it expects to begin selling a once-weekly version of its diabetes drug, Byetta, by the end of the year. The company reports that the FDA is nearing final inspections of its manufacturing plant and could give the go-ahead for U.S. sales in early March.

comments 2 comments - Posted Mar 4, 2010

August 2009

Liraglutide Tested on African Americans with Type 2 Diabetes

Most clinical studies of new drugs are conducted primarily on white men, whether or not they are most affected by the disease the drug is intended to treat.  African Americans, for example, are 1.6 times more likely to have diabetes than non-Hispanic whites.  Why should we assume that what works for white males will also be effective for African Americans, Hispanics, Asians, or, for that matter, women?

comments 0 comments - Posted Aug 6, 2009

July 2009

Survey Says Most Endocrinologists and Physicians See a Need for More Byetta and Januvia-Type Drugs

High percentages of endocrinologists, primary care physicians, and managed care organizations surveyed by a research firm say they would like to see additional GLP-1 analogues like Amylin/Eli Lilly's Byetta® and DPP-IV inhibitors like Merck's Januvia® available to treat type 2 diabetes.

comments 6 comments - Posted Jul 25, 2009

June 2009

Research Disputes FDA Claim that Exenatide Increase Risk of Acute Pancreatitis

In 2008, the U.S. Food and Drug Administration published strong warnings that the type 2 diabetes drug exenatide (trade name Byetta) might increase risk of acute pancreatitis, a painful inflammation of the pancreas. The FDA's action came in the wake of reports that 30 exenatide users had come down with pancreatitis and that six of them had died from the condition.

comments 1 comment - Posted Jun 19, 2009

May 2009

Amylin Cuts Workforce, Asks FDA to Approve Once-Weekly Byetta

It has been an interesting month for San Diego-based Amylin Pharmaceuticals Inc., the co-manufacturer of Byetta (exenatide) with Eli Lilly & Co., and Alkermes Inc. First, the company announced that it will reduce its sales force by 35 percent-200 employees-in hope of saving $20 million this year and $45 million annually starting in 2010. The company plans to retain 325 representatives to sell its diabetes products to doctors and endocrinologists. At the same time, Amylin has petitioned the FDA to approve the marketing of Byetta LAR, a form of the type 2 drug that requires injection only once a week.

comments 1 comment - Posted May 11, 2009

Type 2 Drugs: EU Approves “Victoza,” FDA Extends Review of “Onglyza”

The European Union's drug regulation agency has recommended that the EU approve the marketing of "Victoza" (liraglutide), a type 2 drug developed by Novo Nordisk.

comments 2 comments - Posted May 6, 2009

April 2009

Long-Acting Byetta Tops Two Other Diabetes Drugs in Direct Comparison

Results from DURATION-2, a 26-week test comparing the diabetic drugs Januvia, Actos, and experimental long-acting Byetta (Byetta LAR) show that Byetta produced lower A1c's and more weight loss than the other two drugs.

comments 5 comments - Posted Apr 15, 2009

Altea Partners With Amylin and Lilly to Develop 12-Hour Byetta Skin Patch

Buoyed by its recent successful phase 1 human clinical trial of a patch that delivers basal insulin through the skin, Atlanta-based Altea Therapeutics says it will work with Eli Lilly and Company and Amylin Pharmaceuticals, Inc., to develop a daily transdermal patch that deliver sustained levels of Byetta (exenatide). The patch, in a 12- and a 24-hour form, will use the company's proprietary PassPort Transdermal Delivery System. Lilly and Amylin will fund all development, manufacturing, and marketing activities for the product. 

comments 2 comments - Posted Apr 7, 2009

March 2009

FDA Poised to Review Two New Drugs for Type 2 Diabetes

The FDA has announced that starting in early April, its Endocrinologic and Metabolic Drugs Advisory Committee will begin looking into two new drugs for type 2 diabetes: saxagliptin tablets from Bristol-Meyers Squibb and liraglutide, an injection drug from Novo Nordisk.

comments 1 comment - Posted Mar 24, 2009

December 2008

FDA Unlikely to Approve Byetta Monotherapy Soon
FDA Unlikely to Approve Byetta Monotherapy Soon

Hopes that the U.S. Food and Drug Administration would move soon to make the diabetes drug Byetta a monotherapy are fading. It now appears that the FDA will extend its review of the drug into 2009.

comments 5 comments - Posted Dec 15, 2008

October 2008

How Diabetes Topics in the News Can Start to Feel Like a Game of “Telephone”

A recent Wall Street Journal article shows once again how misinformation about diabetes-related topics can be spread by even the most expert journalists.

comments 3 comments - Posted Oct 27, 2008

Amylin’s Woes Mount, Thanks to FDA Actions

The stock of Byetta manufacturer Amylin Pharmaceuticals has lost more than half of its value over the past eight weeks, thanks to FDA concerns that the type 2 treatment may be connected with the deaths from acute pancreatitis of six Byetta users. Although the FDA has not proven a direct association between fatal pancreatitis and the use of Byetta, Amylin's stock has fallen nevertheless.

comments 0 comments - Posted Oct 13, 2008

September 2008

Good News for Byetta (Exenatide): Canadian Study Reports Once-Weekly Dose Is Better at BG Control Than Twice Daily

A Canadian clinical study has delivered a double dose of good news for proponents of exenatide (sold commercially as Byetta), a drug used by more than 700,000 Americans to control blood glucose, ease food cravings, and, incidentally, lose weight.  

comments 3 comments - Posted Sep 11, 2008

August 2008

Byetta Takes a Beating as Feds Question Its Safety; Defender Chides FDA for Bureaucracy and Bad Science

Byetta has had a tough past few days. A lawsuit by a Virginia man alleges that the drug caused his life-threatening bout of severe pancreatitis, and there are rumblings from the U.S. Food and Drug Administration that it may force Byetta's makers to attach a "black box" warning to its container and packaging-a stern, highlighted caution about potentially dangerous, even fatal, side effects. 

comments 19 comments - Posted Aug 28, 2008

July 2008

Byetta Breaks the Piggy Bank

San Diego-based Amylin Pharmaceuticals, Inc., posted a second-quarter loss of $64.8 million, or 47 cents per share. This compares to a 2007 second-quarter loss of 45 million, or 34 cents a share.

comments 1 comment - Posted Jul 31, 2008

April 2008

Can Byetta Be a Standalone Treatment for Type 2?

Since its introduction in 2005, Byetta has become “the talk of the town” as one of the most powerful, yet benign, diabetes drugs of the 21st century.

comments 4 comments - Posted Apr 2, 2008

February 2008

The Beneficial Effects of Byetta: An Interview With Amylin
The Beneficial Effects of Byetta: An Interview With Amylin

SK: We’re joined on our show by Craig Eberhard, vice president of sales at Amylin Pharmaceuticals. Hey, Craig, thanks for coming on the show. Amylin has one of the most innovative products that I’ve heard of in years. It’s called Byetta.

comments 8 comments - Posted Feb 1, 2008

December 2007

Byetta Dusts Insulin In Year-Long Trial

In a recent randomized study, 69 people with type 2 diabetes who were already taking metformin were given either Byetta or Lantus for a full year. When the results were in, Byetta came out ahead on several fronts.

comments 10 comments - Posted Dec 11, 2007

November 2007

Warning About Byetta and Pancreatitis

The FDA has received thirty reports of acute pancreatitis (rapid-onset inflammation of the pancreas) in type 2 patients taking Byetta. Twenty-seven of the thirty patients had one or more risk factors for acute pancreatitis, such as gallstones or alcohol use.

comments 1 comment - Posted Nov 5, 2007

July 2007

Once-Weekly Byetta LAR (exenatide long-acting release): So Far, It Works
Once-Weekly Byetta LAR (exenatide long-acting release): So Far, It Works

It's a fact that Byetta reduces A1c's, post-meal and fasting glucose levels, and weight in people with type 2 diabetes. The drawback is that it's another injection twice a day. In response, Amylin, the maker of Byetta, has developed exenatide LAR, a form of Byetta that is injected only once a week.

comments 0 comments - Posted Jul 13, 2007

June 2007

Ginger Graham, former CEO of Amylin
Ginger Graham, former CEO of Amylin

I recently had the privilege of interviewing Ginger Graham, the CEO who led Amylin during the launch of its two first-in-class medicines, Byetta and Symlin.  A fascinating woman with a very personal leadership style, she had the following to say about her past achievements and her future hopes.

comments 0 comments - Posted Jun 1, 2007

May 2007

New Type 2 Drugs Januvia and Byetta Offer Big Benefits
New Type 2 Drugs Januvia and Byetta Offer Big Benefits

The 21st century may be remembered as the time when diabetes became a worldwide epidemic. However, it may also be known as the time when the disease was cured.

comments 8 comments - Posted May 3, 2007

April 2007

Byetta Approved for Use with TZDs
Byetta Approved for Use with TZDs

In December 2006, the injected medication Byetta was approved by the FDA for people with type 2 diabetes who are taking a thiazolidinedione (TZD), but don’t have good control of their blood sugar.

comments 0 comments - Posted Apr 14, 2007

Byetta: Let’s Talk campaign

Ask yourself: Do I know someone who consistently reaches for a donut over oatmeal, has a standing date with their TV instead of the gym or prefers high-calorie, high-fat fast food to healthy meals? If you answered yes, you may know someone who has type 2 diabetes or is at high risk for developing it.

comments 1 comment - Posted Apr 4, 2007

August 2006

Me and My Byetta
Me and My Byetta

Byetta, which came on the market last year, was developed to help people with type 2 diabetes who weren’t getting adequate blood glucose control using other drugs. Any associated weight loss was only incidental.

comments 16 comments - Posted Aug 1, 2006

April 2006

Byetta Changes How You Can Treat Your Type 2 Patients
Byetta Changes How You Can Treat Your Type 2 Patients

John H. Holcombe, MD, is a clinical associate professor of pediatrics at the Indiana University School of Medicine and medical fellow, diabetes, for Eli Lilly and Co.

comments 0 comments - Posted Apr 1, 2006

Byetta Added to Type 2 Regimens Improves Control
Byetta Added to Type 2 Regimens Improves Control

A recent study compared the effect of adding exenatide (Byetta) or insulin glargine (Lantus) to type 2 patients’ treatment regimens. The type 2s previously had been taking metformin and a sulfonylurea with little success.

comments 0 comments - Posted Apr 1, 2006

January 2006

Byetta Matches Lantus for Type 2 Control

Exenatide (Byetta) and insulin glargine (Lantus) achieve similar improvements in overall blood glucose control in people with type 2 diabetes who were not being controlled sufficiently on oral combination therapy.

comments 0 comments - Posted Jan 1, 2006

July 2005

Byetta Now Available for Type 2s

“People who are no longer successful on oral agents can now add Byetta [exenatide] instead of insulin,” says Anne Peters, MD, director of the USC Clinical Diabetes Programs.

comments 1 comment - Posted Jul 1, 2005

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