VALENCIA, Calif.—MannKind Corporation, which specializes in the discovery, development and commercialization of therapeutic products for diseases such as diabetes, has announced that it has received approval from the U.S. Food and Drug Administration (FDA) for AFREZZA (insulin human) Inhalation Powder for improving glycemic control in adult patients with diabetes mellitus. For patients with type 1 diabetes mellitus, AFREZZA must be used in combination with a long-acting insulin.
AFREZZA is a novel, rapid-acting inhaled insulin therapy developed to help improve glycemic control in diabetic adults. The product is delivered via an inhaler, and when administered at the start of a meal, the powder rapidly dissolves upon inhalation to the deep lung, delivering insulin into the bloodstream quickly. Peak insulin levels are achieved within 12 to 15 minutes following administration, and decline to baseline by roughly three hours.
“Approval of AFREZZA is an important milestone for MannKind, as today’s FDA action validates the years of clinical research and commitment that powered the development of this unique therapy,” Alfred Mann, CEO of MannKind Corporation, commented in a statement. “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. We thank the more than 6,500 adult patients and healthy volunteers who participated in the AFREZZA clinical program.”
At present, some 29.1 million people in the United States are living with diabetes mellitus, according to the Centers for Disease Control and Prevention. The condition is characterized by the body’s inability to properly regulate blood glucose levels. While insulin usually regulates the body’s glucose levels, patients with diabetes mellitus either produce insufficient levels of insulin, or the body fails to respond adequately to the insulin it produces. This is usually treated with injections of insulin, however, injected forms of insulin tend to be absorbed into the bloodstream slower than naturally produced insulin would be.
“The FDA approval of AFREZZA provides healthcare professionals with an important new safe and effective treatment option for patients with diabetes,” Dr. Janet McGill, professor of Medicine at Washington University School of Medicine, said in a press release. “We have seen in clinical studies that the combination of rapid action, injection-free delivery and ease of use makes AFREZZA a welcome alternative for many patients who require insulin.”
Despite the positive news of the approval, it is mitigated by a number of limitations. The approval comes with a boxed warning that the use of AFREZZA has caused acute bronchospasm in patients with asthma and chronic obstructive pulmonary disorder, and is contraindicated for patients with such lung diseases. AFREZZA is also not recommended for the treatment of diabetic ketoacidosis or for patients who smoke. The product has been approved with a Risk Evaluation and Mitigation Strategy required by the FDA to ensure its benefits outweigh the potential risk of acute bronchospasm in chronic lung disease patients.
SOURCE: MannKind press release