2014-04-16 06:01 AM
WASHINGTON (AP) -- The Food and Drug Administration said Tuesday it approved a new injectable drug from GlaxoSmithKline plc for adults with Type 2 diabetes.
The agency cleared the company's drug, Tanzeum, to help patients control their blood sugar levels, in combination with diet and exercise.
Glaxo's new drug is part of the GLP-1 agonist class of drugs, which includes two other popular injected diabetes drugs, Byetta and Bydureon. GLP-1 is a hormone that helps regulate blood sugar levels.
More than 25 million Americans and 33 million people in Europe have Type 2 diabetes, which impairs production or use of insulin to break down food into energy. That causes blood sugar to rise, putting them at risk of heart and other problems.
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.
Shares of GlaxoSmithKline plc rose 48 cents Tuesday to close at $52.32 in trading.