FDA approves new type 2 diabetes drug

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.

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.

add to favorites email to friend print save as pdf

Related Stories

Common diabetes treatment could extend hypoglycaemia

Apr 08, 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

Feb 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.

Recommended for you

FDA OKs Cubist antibiotic for serious infections

23 hours ago

The Food and Drug Administration has approved a new medicine to fight complex infections in the abdomen and urinary tract, the fourth antibiotic the agency has approved since May.

Xtoro approved for swimmer's ear

Dec 18, 2014

(HealthDay)—Xtoro (finafloxacin otic suspension) eardrops have been approved by the U.S. Food and Drug Administration to treat swimmer's ear, clinically known as acute otitis externa.

Drug interaction identified for ondansetron, tramadol

Dec 18, 2014

(HealthDay)—In the early postoperative period, ondansetron is associated with increased requirements for tramadol consumption, according to a review and meta-analysis published online Dec. 10 in Anaesthesia.

New system targets germs in donated blood plasma

Dec 17, 2014

(HealthDay)—A new system designed to eliminate germs in donated blood plasma and reduce the risk of transmitting a plasma-borne infection has been approved by the U.S. Food and Drug Administration.

User 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.