MannKind Announces FDA Approval of Updated Afrezza® Label Providing Starting Dose Guidance when Switching from Multiple Daily Injections (MDI) or Insulin Pump Mealtime Therapy

Core Viewpoint - MannKind Corporation announced the FDA's approval of an updated prescribing information for Afrezza, which includes revised recommendations for starting mealtime dosages when transitioning patients from subcutaneous insulin to inhaled insulin [1][2]. Group 1: FDA Approval and Label Update - The updated label aims to provide clearer guidance for healthcare providers on starting doses when switching patients to Afrezza from subcutaneous insulin [2]. - The label update is supported by modeling data and results from the Dose Optimization study and the INHALE-3 trial, which showed improved postprandial glucose outcomes with the new dosing recommendations [2][4]. Group 2: Recommended Dosing Information - The revised dosing recommendations include specific conversions from injected mealtime insulin to Afrezza, such as: - Up to 3 units of subcutaneous insulin corresponds to 4 units of Afrezza - 4 to 5 units corresponds to 8 units - 6 to 7 units corresponds to 12 units [5][4]. Group 3: Product Overview - Afrezza is the only ultra-rapid acting inhaled insulin approved by the FDA for improving glycemic control in adults with diabetes mellitus, utilizing MannKind's Technosphere technology for rapid absorption [6]. - The product is administered at the beginning of meals using a portable inhaler, mimicking the body's natural insulin response [6]. Group 4: Safety Information - Afrezza is contraindicated in patients with chronic lung diseases such as asthma or COPD due to the risk of acute bronchospasm [7][12]. - The most common adverse reactions associated with Afrezza include hypoglycemia, cough, and throat irritation [18].