Teva Announces FDA Approval of AirDuo® Digihaler™ – First Digital Maintenance Inhaler Therapy for Asthma
Jul 18, 2019 10:35
CST Updated
10:35
Teva
Drug Developer
FDA
U.S. Food and Drug Administration
July 18, 2019/BioonBIOON/-- Israeli pharmaceutical giant Teva recently announced that the U.S. Food and Drug Administration (FDA) has approved Airduo® Digihaler™ (fluticasone propionate/salmeterol, 113 mcg/14 mcg) inhalation powder, a combination therapy digital inhaler with a built-in sensor that connects to a companion mobile application to provide asthma patients with information on inhaler use. Notably, Airduo® Digihaler™ is the first digital maintenance asthma inhaler therapy with an integrated sensor, indicated for patients aged 12 years and older.AsthmaFor patient treatment, this product is not indicated for the relief of acute respiratory symptoms and should not replace a rescue inhaler.
Tushar Shah, M.D., Head of Global Specialty Clinical Development at Teva, stated, “We are pleased to expand the Digihaler™ portfolio to now include a maintenance therapy. With the approval of this product,”AsthmaPatients can now track the frequency of their inhaler use. Empowering patients to monitor their maintenance inhaler usage may facilitate discussions with their physicians regarding treatment adherence and proper technique.
The built-in sensors in AirDuo® Digihaler™ detect when the inhaler is used and measure inspiratory flow rate. These data are then wirelessly transmitted via Bluetooth technology to a companion mobile application, allowing patients to view their treatment data at any time and share it with their healthcare providers if needed. Patients can also set reminders on their smartphones to ensure adherence to the prescribed AirDuo® Digihaler™ treatment regimen.
The approval of Airduo® Digihaler™ was based on Teva's submission toFDAReview of the submitted supplemental New Drug Application (sNDA). Airduo® Digihaler™ combines a breath-actuated, multi-dose dry powder inhaler with fluticasone propionate/salmeterol, where fluticasone propionate is an inhaled corticosteroid (ICS) that helps reduce lung inflammation, and salmeterol is a long-acting beta2-adrenergic agonist (LABA) that helps keep the muscles around the airways in the lungs relaxed to prevent symptoms.
Airduo® Digihaler™ is approved for administration at low, medium, and high doses: 55/14 mcg, 113/14 mcg, and 232/14 mcg, twice daily, as a fixed-dose combination containing an ICS and a LABA.AsthmaThe therapy, Airduo® Digihaler™, contains the same active ingredients as Advair Diskus® (Seretide). This product is approved for administration at low, medium, and high doses: 100/50 mcg, 250/50 mcg, and 500/50 mcg.
Dr. Nabeel Farooqui, Assistant Professor in the Department of Medicine at Indiana University School of Medicine, stated: “Even the most diligentAsthma"Patients, despite their best efforts, may not realize they are not adhering to their treatment regimen. Now, being able to measure their inspiratory flow rate and track their maintenance medication usage, as well as how frequently they use their inhalers, can provide important data and insights to facilitate therapeutic discussions with physicians. As a doctor, I find it exciting that my patients can share this type of information with me."(Bio Valley Bioon.com)