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Inhaled insulin Afrezza approved for mealtime use

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Afrezza, an inhaled insulin has been approved by the FDA as a new treatment for diabetic adults requiring mealtime dosages to control their blood sugar levels, and “can be used at the beginning of a meal or within 20 minutes after the start of a meal,” according to Dr.Jean-Marc Guettier director of the Division of Metabolism and Endocrinology Products in the FDA's Center for Drug Evaluation and Research. "Today's approval broadens the options available for delivering mealtime insulin in the overall management of patients with diabetes who require it to control blood sugar levels."

Insulin is a peptide hormone, produced by beta cells in the pancreas, and is central to regulating carbohydrate and fat metabolism in the body. It causes cells in the skeletal muscles, and fat tissue to absorb glucose from the blood, and is vital to all animal life (except insects), and functions the same way in every one from netmatode worms to dogs, cats, moose and humans, etc. Diabetes mellitus type 1, however occurs when the body’s autoimmune system destroys the beta cells in the pancreas. The resulting lack of insulin leads to dangerous levels of glucose in the blood and urine that can prove life-threatening if not replaced through artificial means (up until now via injection).

Nearly 26 million people throughout the US now suffer from some form of diabetes, with the number expected to rise dramatically over the next few years. Most, however, are diagnosed with Type 2 diabetes, in which their bodies are unable to adequately process the blood sugars. I n addition to certain medications, most cases of Type 2 diabetes can be controlled (or even reversed) through weight loss, exercise and proper diets. Clinical trials for Afrezza were conducted on 1,026 patients with Type 1 diabetes, and 1,991 with Type 2.

It should be noted, however, that the FDA said Afrezza was not a substitute for long-acting insulin and “must be used in combination with long-acting insulin for patients with type 1 diabetes. It also can't be used to treat diabetec ketoacidosis or by patients who smoke.”



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