FDA approves Albiglutide [Tanzeum] to treat type 2 diabetes

Last Updated on April 16, 2014 by Joseph Gut – thasso

April 16, 2014 – The U.S. Food and Drug Administration (FDA)  yesterday  approved Tanzeum (albiglutide) subcutaneous injection to improve glycemic control, along with diet and exercise, in adults with type 2 diabetes. Type 2 diabetes affects approximately 24 million people and accounts for more than 90 percent of diabetes cases diagnosed in the United States. Over time, high blood sugar levels can increase the risk for serious complications, including heart disease, blindness, and nerve and kidney damage. “Tanzeum is a new treatment option for the millions of Americans living with type 2 diabetes,” said Curtis Rosebraugh, M.D., M.P.H., director of the Office of Drug Evaluation II in the FDA’s Center for Drug Evaluation and Research. “It can be used alone or added to existing treatment regimens to control blood sugar levels in the overall management of diabetes.”

Tanzeum is a glucagon-like peptide-1 (GLP-1) receptor agonist, a hormone that helps normalize blood sugar levels. The drug’s safety and effectiveness were evaluated in eight clinical trials involving more than 2,000 patients with type 2 diabetes. Patients participating in the trials showed an improvement in their HbA1c level (hemoglobin A1c or glycosylated hemoglobin, a measure of blood sugar control). Tanzeum has been studied as a stand-alone therapy and in combination with other type 2 diabetes therapies, including metformin, glimepiride, pioglitazone, and insulin. Tanzeum should not be used to treat people with type 1 diabetes; those who have increased ketones in their blood or urine (diabetic ketoacidosis); or as first-line therapy for patients who can’t be managed with diet and exercise.

Tanzeum has a Boxed Warning to warn that tumors of the thyroid gland (thyroid C-cell tumors) have been observed in rodent studies with some GLP-1 receptor agonists, but that it is unknown whether Tanzeum causes thyroid C-cell tumors, including a type of thyroid cancer called medullary thyroid carcinoma (MTC), in humans. Tanzeum should not be used in patients with a personal or family history of MTC or in patients with Multiple Endocrine Neoplasia syndrome type 2 (a disease where patients have tumors in more than one gland in their body and that predisposes them to MTC).
The FDA is requiring the following post-marketing studies for Tanzeum:

  • a clinical trial to evaluate dosing, efficacy, and safety in pediatric patients;
  • a medullary thyroid carcinoma (MTC) case registry of at least 15 years duration to identify any increase in MTC incidence related to Tanzeum;
  • a cardiovascular outcomes trial (CVOT) to evaluate the cardiovascular risk of Tanzeum in patients with high baseline risk of cardiovascular disease.

In clinical trials, the most common side effects observed in patients treated with Tanzeum were diarrhea, nausea, and injection site reactions. The FDA approved Tanzeum with a Risk Evaluation and Mitigation Strategy (REMS), which consists of a communication plan to inform health care providers about the serious risks associated with Tanzeum.

Tanzeum is manufactured by GlaxoSmithKline, L.L.C., Wilmington, Del.

For more information:

 

Ph.D.; Professor in Pharmacology and Toxicology. Senior expert in theragenomic and personalized medicine and individualized drug safety. Senior expert in pharmaco- and toxicogenetics. Senior expert in human safety of drugs, chemicals, environmental pollutants, and dietary ingredients.

Your opinion

Comment

@peepso_user_30549(sajibuni)
Hello Everyone out there,I am here to give my testimony about a Herbalist doctor who helped me . I was infected with HERPES SIMPLEX VIRUS five years ago, i went to many hospitals for cure but there was no solution, so I was thinking how can I get a solution out so that my body can be okay. One day I was in the river side thinking where I can go to get solution. so a lady walked to me telling me why am I so sad and i open up all to her telling her my problem, she told me that she can help me out, she introduce me to a doctor who uses herbal medication to cure HERPES SIMPLEX VIRUS and gave me his email, so i mail him. He told me all the things I need to do and also give me instructions to take, which I followed properly. Before I knew what is happening after two weeks the HERPES SIMPLEX VIRUS that was in my body got vanished . so if you are also heart broken and also need a help, you can also email him at dr.chalaherbalhome@gmail.com or Contact him today on whatsapp number +2348165102815 and you will have a testimony. He can also cure other diseases like
CANCER.
HEPATITIS A B&C
DIABETES.
SINUSITIS.
CUSTOPATION.
HERPES SIMPLEX VIRUS.
INFERTTILITY.
HIV AND AIDS
WARTS
MISCARRIAGES
ABSCESS
ANCANTHOMA
ANCANTHOSIS
ACNE.
AND MANY MORE.
CONTACT HIM NOW AND BE FREE FOR LIFE.THANK YOU DR.CHALA FOR THE LIFE YOU HAVE GIVING ME GOD WILL BLESS YOU AND YOUR GOOD WORK
2 years ago