FDA approves once a week diabetes injection: Could you take the drug?
The FDA has announced approval of the type 2 diabetes drug Tanzeum that can helps millions of people with the disease. The injection is a once a week treatment manufactured by the drug company GlaxoSmithKline, L.L.C.
Who can take Tanzeum?
According to 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.”
The drug belongs to a class of antidiabetic medicines known as glucagon-like peptide-1 (GLP-1) receptor agonists. Other examples of GLP-1s include Byetta and Victoza.
The medication is not recommended as a first therapy for diabetics whose sugars levels are not managed with diet and exercise or for type 1 diabetes with ketoacidosis.
Some diabetics could use the drug in conjunction with oral medicines or with insulin.
The drug was evaluated in eight clinical trials that included more than 2000 patients and helped lower HbA1c level (hemoglobin A1c) levels that include Byetta and Victoza.
There is also a “black box” warning that some GlP-1 drugs have caused thyroid tumors in rats. Whether Tanzeum causes tumors of the thyroid is unknown. The FDA will continue to monitor the drug post-marketing. Tanzeum should not be used if you have a family history of medullary thyroid carcinoma (MTC) or a condition known as Multiple Endocrine Neoplasia syndrome type 2 (MEN 2) that is a rare type of familial cancer resulting from a genetic mutation.
There is also a warning that the drug should be stop if pancreatitis develops or is suspected.
What is the cost?
Cost is always a concern when a new drug hits the market. Insulin costs an average of $45 a month for Medicare recipients on most drugs plans, which varies slightly.
You will have to contact your insurance provider to find out if Tanzeum (albiglutide) is included on your formulary. The drug is expected to be available the latter part of this year.
Many drugs are excluded but most insurance plans have a process for having your doctor submit what is called a “formulary exception”.
Type 2 diabetes affects 382 million people worldwide. Diet, exercise and weight loss continue to be the mainstays of type 2 diabetes control. Rosebraugh said in a press announcement, "Tanzeum is a new treatment option for the millions of Americans living with type 2 diabetes."