Afrezza (insulin human) got an approval from the Food and Drug Administration on Friday. This form of insulin is inhaled instead of injecting externally, giving a new option to millions of Americans suffering from diabetes.
Afrezza is a rapid-acting inhaled insulin that is administered at the beginning of each meal, or within 20 minutes after starting a meal.
Afrezza is consumed via a whistle-sized inhaler. It acts more rapidly than injectable insulins such as Eli Lilly and Co’s Humalog and Novo Nordisk’s NovoLog.
“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,” Dr. Jean-Marc Guettier, M.D., director of the Division of Metabolism and Endocrinology Products in the FDA’s Center for Drug Evaluation and Research, said in a statement.
The approval of the drug, Afrezza, came like a dream come true putting an end to a long and expensive journey for its developer, MannKind Corporation, and for its chief executive, Los Angeles billionaire-inventor Alfred E. Mann, an 88-year-old billionaire who spent a big part of his fortune sustaining the company through various setbacks. MannKind Corp. of Valencia, Calif. has spent about $1.8 billion developing the drug, with about $975 million of that coming from Mann’s personal wealth. The inhaled insulin was rejected twice by the F.D.A., forcing MannKind to conduct new clinical trials. MannKind Corporation, conducted additional safety studies after the first two attempts.
The FDA estimates that 18.1 million people have diabetes. About 7 million more are undiagnosed, the agency says.
To evaluate the drug’s safety and effectiveness in a total of 3,017 participants were examined–1,026 participants with type 1 diabetes and 1,991 patients with type 2 diabetes.
The Food and Drug Administration said it cleared Afrezza for Type 1 and Type 2 diabetes.
Afrezza carries a warning as it may cause a sudden tightening of the chest. Patients with chronic lung disease such as asthma or chronic obstructive pulmonary disease have been restrained from the consumption of Afrezza.
The label also recommends the patients who are smokers or who have recently stopped smoking to not use the drug.
An earlier inhaled insulin, Pfizer’s Exubera, has a horrible downfall was forced to be withdrawn from the market. The inhaler for Afrezza is about the size of a referee’s whistle while Exubera’s was the size of a tennis ball can.
The company will also be required to undergo following additional studies: one to evaluate Afrezza’s safety and efficacy in children; a clinical trial to evaluate the potential risk of pulmonary malignancy with Afrezza (this trial will also assess cardiovascular risk and the long-term effect of Afrezza on pulmonary function); and two to further examine the way the drug works and is dosed in the body.