MannKind's Afrezza Inhaled Insulin Approved for Children; Updated Label Provides New Dose Guidance for Adults
FDA approves MannKind's Afrezza inhaled insulin for children aged 6+ with type 1 and type 2 diabetes. Separately, an updated label provides new starting dose guidance for adults switching from injections or insulin pumps.
The U.S. Food and Drug Administration (FDA) has approved MannKind Corporation's Afrezza (insulin human) Inhalation Powder for use in children and adolescents aged 6 and older with type 1 and type 2 diabetes, providing a new needle-free mealtime insulin option for pediatric patients. Separately, the FDA has also approved an update to the Afrezza Prescribing Information that revises recommendations for the starting mealtime dosage when adult patients switch from subcutaneous mealtime insulin regimens, including multiple daily injections or insulin pump therapy.
Afrezza is a fast-acting inhaled insulin formulation delivered through a small, portable inhaler using MannKind's proprietary Technosphere® technology, which enables ultra-rapid absorption through the lungs. The inhaler device slowly brings powder into the lung; a small compartment opens for insertion of the insulin cartridge, the user closes it, and inhalation takes approximately two seconds. It requires no electronics or extra components. The insulin has a fast onset of action and a short duration, more closely mirroring the body's natural insulin response to meals, and can be dosed at the start of meals.
The pediatric approval is supported by results from the Phase 3 INHALE-1 study and extensive clinical data collected over the past two decades. Eligible patients can access Afrezza for $35 or less per month, with support available through MannKind Cares to help facilitate access and coverage.
The updated adult labeling was supported by modeling data and in vivo results from the Dose Optimization study and the INHALE-3 trial, which demonstrated improved postprandial glucose outcomes following conversion to inhaled insulin using the now-approved conversion dose. The revised dosing recommendations provide specific conversion guidance: patients currently using up to 3 units of subcutaneous mealtime insulin should start with 4 units of Afrezza; 4 to 5 units of subcutaneous insulin converts to 8 units of Afrezza; 6 to 7 units converts to 12 units; and 8 or more units converts to 16 units.
Afrezza is contraindicated in patients with chronic lung disease such as asthma or COPD due to the risk of acute bronchospasm, and is not recommended for patients who smoke or have recently stopped smoking. Before initiating therapy, all patients should be evaluated with a medical history, physical examination, and spirometry (FEV1) to identify potential underlying lung disease. Hypoglycemia is the most common adverse reaction associated with insulins, including Afrezza. Other potential serious side effects include decreased lung function and an increased risk of lung cancer.