FDA approves new rapid-acting insulin with a novel delivery method

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diabetes-insulin-afrezzaThe FDA approved a new therapy last week to improve blood sugar control in patients with diabetes primarily type 1 (insulin-dependent). The drug, Afrezza, is a novel short acting insulin formulation administered by inhalation before each meal -- which differs from traditional injectable and longer lasting insulin treatments. Afrezza s introduction to the market is meant to help an estimated 25.8 million people with diabetes in the United States, according to the FDA.

The director of the Division of Metabolism and Endocrinology Products in the FDA s Center for Drug Evaluation and Research, Jean-Marc Guettier, M.D comments: Afrezza is a new treatment option for patients with diabetes requiring mealtime insulin. 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.

After two previous rejections by the federal agency, Afrezza s approval on Friday was based on a study of 3,017 patients: 1,026 type 1 diabetics and 1,991 type 2 diabetics. After 24 weeks of treatment, the type 1 trial illustrated that basal insulin and mealtime Afrezza was equivalent to basal insulin and injectable insulin (NovoLog) in maintaining HbA1c levels (a measure of long-term blood sugar control). Of note, the FDA s press release states that Afrezza yielded less of a reduction in HbA1c level than injectable insulin, which suggests worse long term control of blood sugar. In addition, the type 2 trial showed that patients taking both injectable insulin and Afrezza did better than those taking injectable insulin and placebo.

The FDA cautions consumers by emphasizing the new drug is not an alternative to long-acting insulin. Especially in patients with type 1 diabetes, Afrezza should be taken with long-acting insulin, and it is not recommended for treatment of diabetic ketoacidosis (when the body begins to break down fat as an alternate fuel because of the absence of insulin), or for smokers.

The boxed warning explicitly advises patients with asthma or chronic obstructive pulmonary disease against Afrezza due to observed acute bronchospasms within this patient group. Additionally, common adverse events caused by Afrezza include hypoglycemia, cough, and throat pain or irritation.

For the future, the FDA is requiring post-marketing studies that will study the safety and efficacy of Afrezza in children, evaluate the potential risk of pulmonary malignancy, as well as two additional studies to examine dose response and within subject variability.