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The FDA has approved Tanzeum to treat type 2 diabetes. According to the American Diabetes Association, type 2 diabetes is the most common form of diabetes, accounting for 90-95 percent of diabetes cases.
“Tanzeum is a new treatment option for the millions of Americans living with type 2 diabetes,” posited 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 FDA said it approved the new drug based on eight trials including more than 2,000 patients. The studies showed people taking Tanzeum had significant improvement in measures of blood sugar control.
Tanzeum will carry a boxed warning label about thyroid tumors that have been seen in rodent testing of some GLP-1 drugs. The FDA is requiring Glaxo to maintain a 15-year patient registry looking for any increase in thyroid cancer among Tanzeum patients. The company is also required to complete a cardiovascular safety trial.
Diabetes is a core business area for London-based Glaxo, that was once lucrative, but has been hit by drug safety concerns.
The company’s pill Avandia was the best-selling diabetes drug in the world in 2006, until researchers first raised questions about its links to heart attack in 2007. That led to a ban on sales in the European Union and severe restrictions in the U.S. in 2010. In November the FDA lifted those restrictions after a review concluded that the much-debated medication did not increase the risk of heart attack.
Agencies/Canadajournal
