FDA Committee Votes To Approve MannKind's Afrezza For Diabetes
By Cyndi Root
MannKind Corporation announced in a press release that a Food and Drug Administration (FDA) panel has voted to approve Afrezza. The Endocrinologic and Metabolic Drugs Advisory Committee voted 13 to 1 to grant marketing approval to improve glycemic control in adults with type 1 diabetes. The committee voted 14 to 0 to recommend the drug for type 2 diabetes. The FDA is not bound by the committee’s decision but often grants approval based on its opinion and other factors. Alfred Mann, Chairman and CEO of MannKind Corporation said, "We look forward to working with the FDA as they complete their evaluation of Afrezza. Diabetes is a major health problem in the United States, and we are committed to bring Afrezza to the many patients who might benefit from this novel product."
Diabetes
Diabetes is a disease wherein the body does not produce enough insulin or does not use insulin efficiently. When ingested food is metabolized into glucose, insulin must be present in order for the glucose to permeate the cells. The pancreas, a gland behind the stomach, produces insulin in healthy people. For diabetics, however, insulin deficiency causes glucose to accumulate in the blood and pass into the urine without providing the person with the energy from food.
Afrezza
Afrezza is a fast-acting agent taken at mealtime. It improves glycemic control in adults with type 1 or type 2 diabetes. The drug-device combination product is a powder in a small inhaler. Patients take the drug just before meals. The powder dissolves quickly, penetrating through the lungs into the bloodstream. Within 12 to 15 minutes, peak insulin levels are achieved. Competing products take 45 to 150 minutes to work.
The Afrezza clinical program, which is ongoing, enrolled over 6,500 patients. Studies compared Afrezza to standard insulin treatments and found reductions in HbA1c, reduced risk of hypoglycemia, and less weight gain. The inhaler delivery of Afrezza frees patients from injections. Some patients experienced minor changes in lung function but these resolved after discontinuing Afrezza. A mild cough was the most common side effect.
About MannKind
MannKind Corporation’s headquarters is in California. The company focuses on treatments for cancer and diabetes. Alfred E. Mann, the founder, merged three companies in 2003 into the present form. Afrezza uses MannKind’s proprietary Technosphere formulation technology, which enables the pulmonary administration of therapeutics currently requiring administration via injection.MannKind expects a decision from the FDA on Afrezza by April 15, 2014.