The inhaled insulin Afrezza has been recommended for approval by a Food and Drug Administration (FDA) advisory committee.
The drug, an inhaled powder, completed phase III testing in August of 2013. If approved, it will be the first ultra rapid-acting mealtime insulin therapy available in the United States.
The advisory committee recommended that the drug be granted marketing approval by the FDA to help improve glycemic control in adults with both type 1 and type 2 diabetes.
“We are pleased with the advisory committee’s approval recommendation in support of Afrezza, and we appreciate the thoroughness of their review,” said Alfred Mann, Chairman and CEO of MannKind Corp., which manufactures the drug. “We look forward to working with the FDA as they complete their evaluation.”Prior to this point, MannKind conducted more than 50 studies that included more than 5,300 adults with diabetes. The inhaled insulin – a patented insulin that behaves more like the insulin released by the pancreas – was showed to reduce blood glucose fluctuations after meals, and also led to lower blood sugar levels, a lower risk of hypoglycemia and less weight gain when compared to injectable insulin and oral therapies.
“We believe that Afrezza has the potential to change diabetes therapy by offering significant benefits to the growing population of patients with diabetes,” a company spokesperson said.
About 30 percent of those using the drug reported a dry, intermittent cough, which was the only reported side effect, which didn’t last beyond the first week of treatment.
The FDA will take the recommendation into consideration when it reviews the drug, a process that is expected to be completed by April 15th.