MannKind Corporation announced that the U.S. Food and Drug Administration (FDA) has approved an update to the Prescribing Information for Afrezza®? (insulin human) Inhalation Powder, revising recommendations for the starting mealtime dosage when patients switch from subcutaneous mealtime insulin regimens. The updated labeling was supported by modeling data and in vivo results from the Dose Optimization study and the INHALE-3 trial that demonstrated improved postprandial glucose outcomes following conversion to inhaled insulin using the now-approved conversion dose.
The revised dosing recommendations, provided in the table below, include recommended dose conversions from injected mealtime insulin or insulin pump bolus dosing to the appropriate mealtime dosage of Afrezza and are intended to support a clinically appropriate and safe transition for adult patients initiating Afrezza. Please see the Full Prescribing Information for additional details. Afrezza (pronouncedUh-frezz-uh) Inhalation Powder is the only ultra rapid-acting inhaled insulin approved by the U.S. food and Drug Administration to improve glycemic control in adult patients with diabetes mellitus.
Administration at the beginning of meals using a small, portable inhaler, Afrezza delivers insulin via MannKind's proprietary Technosphere®? technology, enabling ultra-rapid absorption through the lungs. Afrezza causes a decline in lung pulmonary function over time as measured by FEV1.
In clinical trials excluding patients with chronic lung disease and lasting up to 2 years, Afrezza-treated patients experienced a small (40mL) but greater FEV1 decline than comparator-treated patients. Assess pulmonary function with spirometry at baseline, after the first 6 mon ths of therapy and annually thereafter even in the absence of pulmonary symptoms. If symptoms persist, discontinue Afrezza. In clinical trials, 2 cases of lung cancer were observed in patients exposed to Afrezza while no cases were reported for the comparators.
In both cases, a prior history of heavy tobacco use was identified as a risk factor for lung cancer. In patients with active lung cancer, a prior history of lung cancer, or in patients at risk of lung cancer, consider whether the benefits of Afrezza use outweigh this potential risk. In clinical trials enrolling patients with type 1 diabetes, diabetic ketoacidosis (DKA) was more common in Afrezza-treated patients (0.43%; n=13) than in comparator-treated patients (0.14%; n=3).
Patients with type 1 diabetes should always use Afrezza concomitantly with basal insulin. These forward-looking statements are based upon MannKind's current expectations. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, which include, without limitation, risks associated with developing and commercializing product candidates and other risks detailed in MannKind's filings with the Securities and Exchange Commission ("SEC"), including under the "R Securities and Exchange Commission ("SEC").
