A Sweet Life » Byetta

Byetta Improves Beta-Cell Function in Type 2 Diabetics

A Sweet Life Staff — Sun, 27 Jun 2010 11:12:24 +0000

Amylin Pharmaceuticals, Inc. and Eli Lilly and Company announced results from a study comparing the effect of long-term treatment with either Byetta (exenatide) injection or Lantus(R) (insulin glargine) on overall beta-cell function. Three years of Byetta therapy improved indices of beta-cell function assessed four weeks after discontinuing therapy. These findings were presented at the 70th Annual Scientific Sessions of the American Diabetes Association in Orlando, Fla.

After three years of treatment, both therapies reduced A1C similarly (by 0.7 percentage points to 6.6 percent for Byetta and by 0.5 percentage points to 6.9 percent for Lantus). In addition, Byetta significantly reduced body weight compared to Lantus (17-pound difference between groups). After completion of three years of therapy, a four-week off-drug period followed to allow assessment of parameters of metabolic state including beta-cell function. Beta-cell function was assessed using a calculated disposition index (insulin secretion adjusted for insulin sensitivity). Byetta increased insulin sensitivity by 39 percent and increased the disposition index, indicating an improvement in background beta-cell function. Lantus had no effect on insulin sensitivity or disposition index.

“Type 2 diabetes is a progressive disease in which insulin production typically decreases over time,” said Michaela Diamant, M.D., professor of diabetology, director, Diabetes Center VUMC, Amsterdam, the Netherlands, and principal investigator of the study. “These findings suggest that with extended use, Byetta treatment may help improve insulin production and help people with type 2 diabetes better control their blood sugar levels.”

Byetta Helps Type 2 Diabetics Achieve Blood Glucose Control

A Sweet Life Staff — Sun, 27 Jun 2010 10:11:09 +0000

Amylin Pharmaceuticals, Inc. and Eli Lilly and Company announced results from the first double-blind, placebo-controlled clinical study to evaluate BYETTA(R) (exenatide) injection added to Lantus(R) (insulin glargine), which showed patients with type 2 diabetes achieved glucose targets without weight gain or increasing their risk of hypoglycemia. These findings were presented at the 70th Annual Scientific Sessions of the American Diabetes Association (ADA) in Orlando, Fla.

In the study, patients receiving insulin glargine, with or without oral agents, were randomized to receive BYETTA or placebo in addition to aggressive insulin titration. After 30 weeks of treatment, A1C decreased by 1.7 percentage points in patients adding BYETTA, compared with a decrease of 1.0 percentage point in patients treated with insulin alone. Weight decreased in patients adding BYETTA by 4 pounds, compared with an increase of 2 pounds in patients treated with insulin alone. Fasting plasma glucose and hypoglycemia were similar between treatment groups.

This study showed BYETTA may provide a complementary addition to basal insulin for hard-to-treat type 2 diabetes patients.

Results from this study will form the basis for a supplemental New Drug Application to the U.S. Food and Drug Administration. The filing is planned for the end of 2010.

Also presented at the ADA 70th Annual Scientific Sessions were final results from a retrospective study including more than 260,000 patients that showed the risk of acute pancreatitis among initiators of BYETTA(R) (exenatide) injection was not increased compared to initiators of other antidiabetic therapies.

New Type 2 Diabetes Drug Bydureon Shows Better Results Than Januvia

A Sweet Life Staff — Wed, 16 Jun 2010 06:08:59 +0000

Amylin Pharmaceuticals, Inc., Eli Lilly and Company and Alkermes, Inc. announced results from DURATION-4, the fourth in a series of studies designed to test the superiority of Bydureon (exenatide extended-release for injectable suspension), an investigational type 2 diabetes therapy, as compared to other type 2 diabetes medications.

The 26-week clinical study compared Bydureon monotherapy to Januvia(R) (sitagliptin), Actos(R) (pioglitazone HCI) or metformin, three oral type 2 diabetes medications commonly prescribed early in the treatment of type 2 diabetes. Study participants were not achieving adequate A1c control using diet and exercise, and were not on any diabetes therapy when they entered the study. After 26 weeks of treatment, patients randomized to Bydureon experienced a reduction in A1c of 1.5 percentage points from baseline, which was significantly greater than the reduction of 1.2 percentage points for Januvia. Patients randomized to metformin experienced a reduction in A1c of 1.5 percentage points, and patients receiving Actos experienced a reduction of 1.6 percentage points. Patients receiving Bydureon, Actos and metformin treatment achieved an average A1c of less than 7 percent by study end.

Treatment with Bydureon produced an average weight loss of 4.5 pounds, which was statistically significantly greater than the average 1.7 pounds patients lost with Januvia and the average 3.3 pounds patients gained with Actos. Patients receiving metformin experienced an average weight loss of 4.4 pounds.

Bydureon is the proposed brand name for exenatide once weekly. It is an investigational, extended-release medication for type 2 diabetes designed to deliver continuous therapeutic levels of exenatide – the active ingredient in Byetta – in a single weekly dose.

FDA Classifies Bydureon Complete Response as a Class 2 Resubmission

A Sweet Life Staff — Thu, 06 May 2010 18:15:43 +0000

Amylin Pharmaceuticals, Inc., Eli Lilly and Company and Alkermes, Inc. announced that the U.S. Food and Drug Administration has classified the Bydureon(TM) complete response as a Class 2 resubmission and assigned a new Prescription Drug User Fee Act (PDUFA) action date of October 22, 2010.

Bydureon (pronounced by-DUR-ee-on) is the proposed brand name for exenatide once weekly. It is an investigational, extended-release medication for type 2 diabetes designed to deliver continuous therapeutic levels of exenatide – the active ingredient in Byetta – in a single weekly dose. Byetta, the first FDA-approved GLP-1 receptor agonist for the treatment of type 2 diabetes, has been available in the U.S. since June 2005 and is used in approximately 60 countries worldwide to improve glycemic control in adults with type 2 diabetes.

Amylin, Lilly and Alkermes Receive FDA Complete Response Letter for Exenatide Once Weekly

A Sweet Life Staff — Mon, 15 Mar 2010 16:42:47 +0000

Amylin Pharmaceuticals Inc., Eli Lilly and Company and Alkermes, Inc. today announced that the U.S. Food and Drug Administration (FDA) has issued a complete response letter regarding the New Drug Application (NDA) for BYDUREON(TM).

In the complete response letter there are no requests for new pre-clinical or clinical trials. Requests raised in the letter primarily relate to the finalization of the product labeling with accompanying Risk Evaluation and Mitigation Strategy (REMS) and clarification of existing manufacturing processes. The companies view this response as a positive step forward.

BYDUREON is the proposed brand name for exenatide once weekly. It is an investigational, extended-release medication for type 2 diabetes designed to deliver continuous therapeutic levels of exenatide in a single weekly dose. BYDUREON is a once-weekly formulation of exenatide, the active ingredient in BYETTA^(R) (exenatide) injection, which has been available in the U.S. since June 2005.

Lilly and Amylin Confirm FDA Extension of Exenatide Once Weekly New Drug Application Review

A Sweet Life Staff — Thu, 25 Feb 2010 18:47:51 +0000

The Food and Drug Administration (FDA) announced that following the closure of FDA building due to extreme weather it was granting a five day extension for the review of Amylin Pharmaceuticals Inc and Eli Lilly and Co’s Exenatide Once Weekly New Drug Application. The new drug is part of a collaboration between the companies started in 2002, which includes the currently available twice daily type 2 diabetes drug Byetta.

Exenatide once weekly is an investigational, extended-release medication for type 2 diabetes designed to deliver continuous therapeutic levels of exenatide in a single weekly dose. The NDA for exenatide once weekly was submitted in May 2009 and accepted by the FDA in July 2009.

Both companies released confirmations of this extension.

Exenatide Once Weekly Provided Superior Glucose Control Compared to Byetta in Tests

A Sweet Life Staff — Wed, 16 Dec 2009 10:35:42 +0000

Amylin Pharmaceuticals, Inc., Eli Lilly and Company and Alkermes Inc. today announced positive results from a head-to-head study comparing exenatide once weekly, an investigational diabetes therapy, to Byetta (exenatide injection taken twice daily), in patients with type 2 diabetes.
The tests showed that after 24 weeks of treatment, patients taking exenatide once weekly experienced a statistically superior reduction in A1C, of 1.6 percentage points from baseline, compared to a reduction of 0.9 percentage points for Byetta. Patients treated with exenatide once weekly achieved a mean A1C of 7.1 percent compared with a mean A1C of 7.7 percent in those treated with Byetta. Both treatment groups achieved statistically significant weight loss by the end of the study, with an average loss of 5.1 pounds for patients taking exenatide once weekly and 3.0 pounds for patients taking Byetta.
These findings are consistent with the results of other studies of exenatide once weekly and Byetta. The companies conducted DURATION-5 to support regulatory submissions outside of the U.S. and provide additional controlled clinical data on the commercially manufactured product. DURATION is a series of clinical trials designed to test the superiority of exenatide once weekly as compared to currently available type 2 diabetes medications.
Approximately 80 percent of patients completed the study. Consistent with previous DURATION trials, the most frequently reported adverse event in both groups was nausea, reported less frequently by exenatide once weekly users (14 percent) than by Byetta users (35 percent). There were no major hypoglycemic events. Cases of minor hypoglycemia in both groups were limited to patients using background sulfonylurea therapy.

Amylin, Lilly and Alkermes submitted a new drug application (NDA) for exenatide once weekly to the U.S. Food and Drug Administration (FDA) in May 2009; the NDA was accepted for review in July 2009. Lilly will be responsible for marketing exenatide once weekly outside the U.S. and expects to submit a marketing application to the European Medicines Agency by the end of the second quarter in 2010.

Novo’s Victoza Awaits Final FDA Approval

A Sweet Life Staff — Thu, 12 Nov 2009 18:17:08 +0000

Novo Nordisk’s CEO, Lars Sorensen, told Reuters at the Reuters Health Summit in New York that the new diabetes drug Victoza has reached the final decision stage at the U.S. FDA. Sorensen expects the drug will be approved, although “potentially all the outcomes are still possible. A rejection is still possible, a demand for refiling is still possible…”

According to Sorensen, Victoza, which was approved in Europe in July, has been achieving rapid uptake in Europe and is set to overtake Eli Lilly’s and Amylin Pharmaceuticals Inc’s rival Byetta treatment in Germany by the end of the year.

The final FDA verdict is expected this month or next.

Novo also sees a future for the Victoza in treating obesity. The drug has produced impressive weight loss results in mid-stage Phase II clinical trials, but final Phase III obesity studies have been put on hold pending the final decision by the FDA.

Byetta Safety Label Revised

A Sweet Life Staff — Tue, 03 Nov 2009 21:31:03 +0000

Today the FDA indicated that the safety label of Byetta would be modified to include potential kidney problems including possible kidney failure. According to the FDA website “From April 2005 through October 2008, the FDA received 78 reports of problems with kidney function in patients using Byetta.” Seven million Byetta prescriptions were issued during this time, so this represents about 1 in 100,000 people being affected.

Byetta is a drug taken to assist in the processing of blood sugar. It is one of a family of drugs known as incretin based therapies. One of the side effects of Byetta, as well as other incretin based therapies, is vomiting. This is thought to play a role in kidney dysfunction.

In February, Diabetes Care published a short report on 4 patients who had suffered serious kidney damage from Byetta therapy, and this may serve as an example of what has happened to the others. All four patients presented with vomiting and decreased fluid intake. Because of their diabetes induced hypertension, they took ACE inhibitors and diuretics. All suffered kidney failure within 2 – 9 months of initiating Byetta therapy and were taken off the treatment upon diagnosis. All recovered some kidney function although recovery was not complete in 3 out of the 4 patients.

The opinion of the authors was that the combination of vomiting (fluid loss), decreased fluid intake, ACE inhibitors, and diuretics created too much of a stress for the kidneys. They did point to a study which shows that the incretin GLP-1 was shown to perhaps decrease kidney function in healthy subjects, however it is not known if Byetta does this or not.

If you have kidney problems you may not want to take Byetta. If you do take Byetta, be sure to keep your fluid levels up by drinking sufficient amounts of water. As with all therapies, consult with your doctor before making any changes.

By: Robert Scheinman

Takeda and Amylin to Co-develop Obesity Treatments

A Sweet Life Staff — Mon, 02 Nov 2009 10:36:17 +0000

Amylin Pharmaceuticals, Inc. and Takeda Pharmaceuticals Company Limited announced an agreement to co-develop and commercialize pharmaceutical products for the treatment of obseity and related conditions. Amylin, whose top product, Byetta, had sales of $678.5 million last year. will receive a one-time up-front payment of $75 million from Takeda, the largest pharmaceutical company in Japan and maker of Actos, a best-selling diabetes drug. In a press release, Takeda writes, “Under the terms of the agreement, Amylin will be responsible for executing development activities for potential products through phase 2 with the aim of regulatory approval in the U.S. Takeda will lead development activities beyond phase 2 in the U.S., and all development activities outside the U.S. ”

Obesity has become a major health problem and has reached epidemic proportions globally, with more than 1 billion adults overweight, and at least 300 million of them obese. Obesity is linked several medical conditions including type 2 diabetes.