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Latest Byetta Articles
Diabetes and Byetta Article Archives
March 2012
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.
0 comments - Posted Mar 29, 2012
February 2012
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.
2 comments - Posted Feb 17, 2012
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.
2 comments - Posted Feb 3, 2012
May 2011
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.
0 comments - Posted May 23, 2011
July 2010
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.
0 comments - Posted Jul 8, 2010
March 2010
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.
0 comments - Posted Mar 29, 2010
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.
2 comments - Posted Mar 4, 2010
August 2009
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?
0 comments - Posted Aug 6, 2009
July 2009
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.
6 comments - Posted Jul 25, 2009
June 2009
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.
1 comment - Posted Jun 19, 2009
May 2009
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.
1 comment - Posted May 11, 2009
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.
2 comments - Posted May 6, 2009
April 2009
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.
5 comments - Posted Apr 15, 2009
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.
2 comments - Posted Apr 7, 2009
March 2009
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.
1 comment - Posted Mar 24, 2009
December 2008
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.
5 comments - Posted Dec 15, 2008
October 2008
A recent Wall Street Journal article shows once again how misinformation about diabetes-related topics can be spread by even the most expert journalists.
3 comments - Posted Oct 27, 2008
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.
0 comments - Posted Oct 13, 2008
September 2008
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.
3 comments - Posted Sep 11, 2008
August 2008
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.
19 comments - Posted Aug 28, 2008
July 2008
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.
1 comment - Posted Jul 31, 2008
April 2008
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.
4 comments - Posted Apr 2, 2008
February 2008
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.
8 comments - Posted Feb 1, 2008
December 2007
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.
10 comments - Posted Dec 11, 2007
November 2007
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.
1 comment - Posted Nov 5, 2007
July 2007
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.
0 comments - Posted Jul 13, 2007
June 2007
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.
0 comments - Posted Jun 1, 2007
May 2007
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.
8 comments - Posted May 3, 2007
April 2007
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.
0 comments - Posted Apr 14, 2007
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.
1 comment - Posted Apr 4, 2007
August 2006
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.
16 comments - Posted Aug 1, 2006
April 2006
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.
0 comments - Posted Apr 1, 2006
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.
0 comments - Posted Apr 1, 2006
January 2006
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.
0 comments - Posted Jan 1, 2006
July 2005
“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.
1 comment - Posted Jul 1, 2005