FDA Requires More Data from Takeda on Alogliptin
Takeda Pharmaceuticals has received a request from the U.S. Food & Drug Administration for additional safety studies on SYR-322, also known by the general name alogliptin, used for diabetes treatment. This will most likely delay the drug's launch in the U.S. market by at least two years while more research is done.
Takeda has its North American headquarters in Illinois. The company holds the patent for top-selling drug, Actos. The patent is due to expire in 2011.
Actos is a once-daily oral medication used in treatment of type 2 diabetes. It can be used alone alone or in combination with insulin, sulfonylureas, or metformin. Actos can cause or worsen congestive heart failure, so must be used with caution in patients with a history of heart failure.
These cardiovascular side effects have been an increased concern of the FDA as noted with their new guidance on cardiovascular programs in December 2008.
Heart failure, also called congestive heart failure, is a life-threatening condition in which the heart can no longer pump enough blood to the rest of the body. It is almost always a chronic, long-term condition, although it can sometimes develop suddenly.
Signs of heart failure include
o Fatigue and weakness
o Rapid or irregular heartbeat
o Shortness of breath (dyspnea) when you exert yourself or when you lie down
o Reduced ability to exercise
o Persistent cough or wheezing with white or pink blood-tinged phlegm
o Swelling (edema) in your legs, ankles and feet
o Swelling of your abdomen (ascites)
o Sudden weight gain from fluid retention
o Lack of appetite and nausea
o Difficulty concentrating or decreased alertness
National Institute of Health