FDA Panel Weighs New Diabetes Drugs
FDA Advisory Committee Considers New Type 2 Diabetes Drugs Onglyza, Liraglutide
April 1, 2009 -- An FDA advisory panel is considering two new drugs to improve blood sugar control in people with type 2 diabetes.
Those drugs, named Onglyza (saxagliptin) and liraglutide, treat high blood sugar (hyperglycemia) in type 2 diabetes patients.
Onglyza, which is taken as a once-daily tablet and is in the same class of drugs as Januvia, is being discussed today by an FDA advisory committee.
In a clinical trial presented last year in Rome, Onglyza trumped a placebo at improving hemoglobin A1c (a gauge of blood sugar control) over the previous two to three months in type 2 diabetes patients who took Onglyza or the placebo along with other diabetes drugs for six months.
The drug companies Bristol-Myers Squibb and AstraZeneca, which are collaborating on Onglyza, are seeking approval for Onglyza as a standalone drug as an adjunct to diet and exercise, and in combination with other diabetes drugs.
Liraglutide, which is given once daily by injection and is in the same class of drugs as Byetta, will be on the advisory panel's agenda on April 2. Liraglutide is made by the drug company Novo Nordisk.
In September 2008, researchers reported in The Lancet that liraglutide was safe and effective, and also helped patients lose weight and lower their blood sugar.
The FDA advisory committee will review data from those trials and consider whether further data about cardiovascular safety are needed for either drug candidate.