Insulin Inhaler Afrezza Approved By FDA

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It took over a decade and nearly $1 billion of his personal fortune but Los Angeles inventor Alfred Mann’s quest to develop an inhalable form of insulin finally won approval from the U.S. Food and Drug Administration (FDA) Friday, according to the Los Angeles Times.

MannKind Corp. of Valencia, Mann’s company, got the approval to sell the drug called Afrezza for Type 1 and Type 2 diabetes, but the FDA added a warning that those with diabetes and asthma or a serious lung disease should not use the drug.

The drug, a powder administered through a device the size of an asthma inhaler, would be most often used at mealtimes to help control blood sugar levels. Although the company has suffered setbacks, with the FDA not approving the drug twice, Mann said he never gave up pursuing his quest.

“I have never considered abandoning the effort because I firmly believe that Afrezza has the potential to bring significant benefits to the still growing and enormous population of people with diabetes,” Mann said

He added, Afrezza “will address many of their unmet needs for mealtime insulin therapy, and has the potential to change the way that diabetes is treated.”

“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,” Dr. Jean-Marc Guettier, director of the FDA's endocrinology division, said in a statement reported by Reuters.

In the United States, diabetes affects 29.1 million people, according to the Centers for Disease Control and Prevention (CDC).

Diabetes is a disease in which blood glucose levels are above normal because the body can’t produce or effectively use insulin, which enables glucose to get into the body’s cells. It can lead to serious health complications and is currently the seventh leading cause of death in the United States.

“Given the current epidemic size and predicted growth of the diabetes patient population we are confident that Afrezza presents a significant commercial opportunity,” Mann said.

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