FDA approves new type 2 diabetes drug

April 15, 2014
FDA approves new type 2 diabetes drug
Tanzeum is injected once a week and appears to help control blood sugar levels, agency says.

(HealthDay)—Millions of Americans with type 2 diabetes have a new treatment option with the U.S. Food and Drug Administration's approval Tuesday of a once-weekly injectable drug, Tanzeum.

The FDA described Tanzeum (albiglutide) as a "glucagon-like peptide-1 (GLP-1) receptor agonist—a hormone that helps normalize patients' blood sugar levels.

Tanzeum "can be used alone or added to existing treatment regimens to control levels in the overall management of ," Dr. Curtis Rosebraugh, director of the Office of Drug Evaluation II in the FDA's Center for Drug Evaluation and Research, said in an agency news release.

The FDA's approval of the drug was based on eight that included more than 2,000 people with type 2 diabetes. Those who took Tanzeum showed improvements in . The drug has also been studied for use in combination with other diabetes medications such as metformin, glimepiride, pioglitazone (Actos) and insulin.

The most common side effects seen with Tanzeum were nausea and/or reactions at the site of injection, the FDA said.

The drug, which is manufactured by GlaxoSmithKline, is not approved to treat Type 1 diabetes, the FDA noted.

The drug will carry a boxed warning stating that the use of some GLP-1 receptor agonists have been associated with thyroid tumors in rodents. The FDA said Tanzeum should not be prescribed for patients with a personal or family history of a type of thyroid cancer called medullary thyroid carcinoma (MTC), or for patients with Multiple Endocrine Neoplasia syndrome type 2. Patients with this disease have tumors in more than one gland in their body and are at increased risk for MTC.

Dr. Spyros Mezitis is an endocrinologist at Lenox Hill Hospital in New York City. He said Tanzeum joins a list of other approved injectable diabetes medicines, including Victoza (liraglutide), Byetta (exenatide) and Bydureon (exenatide extended release).

"Post-marketing clinical trials are planned to examine cardiovascular effects, use in pediatric patients, and possible increase in pancreatitis or medullary thyroid cancer," Mezitis said. "The results of these clinical trials will determine which GLP-1 agonists will be more useful" to patients.

According to the FDA, about 24 million people in the United States have , which accounts for more than 90 percent of all diabetes cases diagnosed in the United States. Over time, the high produced by diabetes can increase the risk for serious complications, including heart disease, blindness, and nerve and kidney damage.

Explore further: US approves diabetes drug with new approach (Update)

More information: The U.S. National Institute of Diabetes and Digestive and Kidney Diseases has more about type 2 diabetes.

The FDA has more about this approval.

Related Stories

US approves diabetes drug with new approach (Update)

January 8, 2014
The U.S. Food and Drug Administration on Wednesday approved a new diabetes drug from Bristol-Myers Squibb and AstraZeneca that uses a novel approach to reduce blood sugar.

FDA approves 3 new drugs for type 2 diabetes

January 26, 2013
(HealthDay)—The U.S. Food and Drug Administration late Friday approved three new medications to help people battle type 2 diabetes.

Common diabetes treatment could extend hypoglycaemia

April 8, 2014
(Medical Xpress)—Researchers at the University of Adelaide have discovered that a common treatment for people with type 2 diabetes could cause longer-than-normal periods of the low blood sugar reaction hypoglycaemia, which ...

Myalept approved for rare fat tissue disorder

February 25, 2014
(HealthDay)—Myalept (metreleptin for injection) has been approved by the U.S. Food and Drug Administration to treat complications of leptin deficiency for people with the congenital or acquired generalized forms of lipodystrophy.

FDA to investigate diabetes drug saxagliptin for possible heart failure risk

February 11, 2014
(HealthDay)—The U.S. Food and Drug Administration announced Tuesday that it will investigate possible links between the diabetes drug saxagliptin and a heightened risk for heart failure among users.

Nexavar approval expanded for common thyroid cancer

November 24, 2013
(HealthDay)—U.S. Food and Drug Administration approval for the anti-cancer drug Nexavar (sorafenib) has been expanded to include late-stage differentiated thyroid cancer, the most common type of thyroid cancer.

Recommended for you

Study suggests ending opioid epidemic will take years

July 20, 2017
The question of how to stem the nation's opioid epidemic now has a major detailed response. A new study chaired by University of Virginia School of Law Professor Richard Bonnie provides extensive recommendations for curbing ...

Team-based model reduces prescription opioid use among patients with chronic pain by 40 percent

July 17, 2017
A new, team-based, primary care model is decreasing prescription opioid use among patients with chronic pain by 40 percent, according to a new study out of Boston Medical Center's Grayken Center for Addiction Medicine, which ...

Private clinics' peddling of unproven stem cell treatments is unsafe and unethical

July 7, 2017
Stem cell science is an area of medical research that continues to offer great promise. But as this week's paper in Science Translational Medicine highlights, a growing number of clinics around the globe, including in Australia, ...

Popular heartburn drugs linked to higher death risk

July 4, 2017
Popular heartburn drugs called proton pump inhibitors (PPIs) have been linked to a variety of health problems, including serious kidney damage, bone fractures and dementia. Now, a new study from Washington University School ...

Most reproductive-age women using opioids also use another substance

June 30, 2017
The majority of reproductive-age and pregnant women who use opioids for non-medical purposes also use at least one other substance, ranging from nicotine or alcohol to cocaine, according to a University of Pittsburgh Graduate ...

At-risk chronic pain patients taper opioids successfully with psychological tools

June 28, 2017
Psychological support and new coping skills are helping patients at high risk of developing chronic pain and long-term, high-dose opioid use taper their opioids and rebuild their lives with activities that are meaningful ...

0 comments

Please sign in to add a comment. Registration is free, and takes less than a minute. Read more

Click here to reset your password.
Sign in to get notified via email when new comments are made.