WASHINGTON – The Food and Drug Administration has approved a new diabetes pill from Boehringer Ingelheim and Eli Lilly for patients who can't control their blood sugar with older medicines.
The agency said Monday it approved Tradjenta tablets for adults with type 2 diabetes. Type 2 is the most common form of diabetes, affecting up to 95 percent of the 24 million people in the U.S. with diabetes.
People with the disease have trouble breaking down carbohydrates, because their bodies have become resistant to the protein insulin. They are at higher risk for heart attacks, kidney problems, blindness and other serious complications.
Tradjenta works by blocking the DPP-4 enzyme, which releases insulin-boosting hormones that help control blood sugar levels. Merck & Co. Inc. and Bristol-Myers Squibb already market similar drugs in the U.S.
Merck's Januvia pill had sales of $954 million last year. Diabetes drugs accounted for $16.9 billion in U.S. sales last year, according to health care data firm IMS Health. The drugs made up the fourth largest prescription drug class by spending, behind cholesterol drugs.
The FDA approved the new medication as a stand-alone treatment or in combination with older diabetes drugs like metformin. Many diabetes patients have to combine drugs to manage their blood sugar levels.
Boehringer and Lilly submitted eight studies of the drug that enrolled more than 3,800 patients. The drug consistently improved blood sugar control when compared to placebo.
The most common side effects of the drug were respiratory infection, sore throat, muscle pain and headache.
Tradjenta, known by the generic name linagliptin, will be distributed with a medication guide explaining the drug's risks to patients.
FDA issued new testing guidelines for diabetes treatments in 2008 after data suggested that GlaxoSmithKline's diabetes pill increases the risk of heart attack. That drug, once a blockbuster medication for the company, is currently only available through a limited prescribing program.
Boehringer is headquartered in Germany, with U.S. offices in Danbury, Conn. Eli Lilly & Co. Inc. is based in Indianapolis.
