Three New Diabetes Drugs Receive Govt. Approval

Three diabetes drugs using the active ingredient alogliptin have obtained the approval of federal regulators.

The diabetes drugs are designed to address the type 2 condition, the most common form of the fast-growing disease.

The US Food and Drug Administration (FDA) gave its formal go-ahead for the diabetes drugs yesterday according to Medscape:

” On January 25, the FDA announced approval of 3 drugs — Nesina (alogliptin) tablets, the fixed-dose combinations Kazano (alogliptin and metformin hydrochloride) tablets, and Oseni (alogliptin and pioglitazone) tablets for use with diet and exercise to improve blood glucose control in adults with type 2 diabetes. All 3 are manufactured by Takeda Pharmaceuticals America, Inc.”

The FDA rejected the alogliptin application in 2009, but evidently further clinical trials convinced the agency to allow the drug to go into wide use. Takeda will be required to submit five “post-marketing” studies for the anti-diabetes drug in connection with it cardiovascular and other risks.

Alogliptin is a selective dipeptidyl peptidase IV inhibitor (DPP-4) that regulates blood glucose levels. According to an FDA official, “Controlling blood sugar levels is very important in the overall treatment and care of diabetes. Alogliptin helps stimulate the release of insulin after a meal, which leads to better blood sugar control.”

The Examiner explains that type 2 diabetes is growing at an epidemic rate in this country:

“Type 2 diabetes, also known as adult onset diabetes, is growing to close to epidemic proportion. The FDA has stated that type 2 diabetes affects more that 24 million people in the United States, with more and more children and adolescents being diagnosed each year. Type 2 diabetes is an extremely serious health issue. Uncontrolled, Type 2 diabetes can lead to serious heart and cardiovascular disease. Type 2 diabetes is also the leading cause of new blindness. Properly prescribed medication, taken in combination with a controlled diet and regular exercise, can greatly lower the risk of serious complications.”

Douglas Cole, Takeda Pharmaceuticals USA president, noted that “Takeda is pleased with the FDA approval of Nesina, Oseni and Kazano for the treatment of type 2 diabetes, a therapeutic category in which we have more than twenty years of clinical and patient experience,” Yahoo! Finance reports.

Do you think the solution to the diabetes epidemic comes in the form of prescription drugs?