FDA Approves MannKind Corp.’s Inhalable Diabetes Drug Afrezza

The U.S. Food and Drug Administration (FDA) has approved MannKind Corp.'s inhalable insulin drug Afrezza. The approval allows diabetics to use inhalers instead of needles to control insulin levels.

The powder helps control blood sugar levels in people suffering from diabetes mellitus. The agency said that the insulin powder should be taken at the beginning of a meal or about 20 minutes after starting a meal.

Around 29.1 million people in the United States suffer from diabetes, according to estimates by the Centers for Disease Control and Prevention.

People suffering from diabetes mellitus have problem controlling blood glucose level. In healthy humans, a hormone called insulin regulates sugar levels in the blood. But in people with diabetes, the body has insufficient levels of glucose or is unable to use the hormone. Currently, diabetics use insulin injections to control glucose level in the blood.

"We are excited for patients, as we believe that Afrezza's distinct profile and non-injectable administration will address many of their unmet needs for mealtime insulin therapy, and has the potential to change the way that diabetes is treated," said Alfred Mann, Chief Executive Officer, MannKind Corporation, in a news release.

The powder is not a substitute for long-acting insulin and should be used with other treatments for the condition, FDA said. The inhalation powder is also not recommended for people who smoke or have diabetic ketoacidosis. The drug should not be used by people with chronic lung disease such as asthma.

"Afrezza is a new treatment option for patients with diabetes requiring mealtime insulin," said Jean-Marc Guettier, M.D., director of the Division of Metabolism and Endocrinology Products in the FDA's Center for Drug Evaluation and Research, according to a news release. "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."

The safety and effectiveness of the drug were evaluated using data from 3,017 participants, of whom 1,026 had type-1 diabetes and 1,991 had type-2 diabetes.

Researchers found that type-1 diabetes patients who received Afrezza plus long-acting insulin had better control over blood glucose levels at the end of the 24-week study than other people who were on placebo plus long-acting insulin.

Afrezza, along with oral anti-diabetic drugs, were also effective in controlling blood sugar levels in people with diabetes type-2, FDA said.

Afrezza will carry a boxed warning that will include information about the risks associated with using the drug, especially in people with chronic lung diseases. FDA has also asked MannKind Corp. to conduct post-marketing research on the drug.

This isn't the first time that inhalable insulin has earned an FDA approval. Pfizer Inc.'s Exubera was in the U.S. market between September 2006 and October 2007, International Business Times reported.