Teva Respiratory, LLC, an affiliate of Teva Pharmaceutical Industries, announced the U.S. Food and Drug Administration (FDA) has approved ArmonAir® Digihaler™ (fluticasone propionate) Inhalation Powder, an inhaled corticosteroid (ICS) delivered via Teva’s Digihaler™ device, which contains built-in sensors and connects to a companion mobile application that provides information on inhaler use to people with asthma. ArmonAir® Digihaler™ is indicated for the maintenance treatment of asthma in patients 12 years and older. ArmonAir® Digihaler™ is not indicated for the relief of acute bronchospasm.
ArmonAir® Digihaler™ joins the approved Digihaler™ portfolio of products, including ProAir® Digihaler™ (albuterol sulfate 117 mcg) Inhalation Powder, which is indicated for use in patients 4 years of age and older to treat or prevent bronchospasm in those who have reversible obstructive airway disease and to prevent exercise-induced bronchospasm, and AirDuo® Digihaler™ (fluticasone propionate and salmeterol) Inhalation Powder, which is indicated for the maintenance treatment of asthma in patients 12 years of age and older. The Digihaler™ device detects when the inhaler is used and measures inspiratory flow rates. These data are then sent to a companion mobile app using Bluetooth® Wireless Technology so that patients can review their data over time, and if desired, share it with their healthcare providers to have more informed discussions about their condition and treatment. Patients also can schedule reminders on their smartphone to take either their ArmonAir® Digihaler™ or AirDuo® Digihaler™ as prescribed. Please view the Important Safety Information for these products below.
“My patients often struggle to remember to take their medicine and track their maintenance and rescue medication usage which can play a significant role in asthma management,” said Dr. Nabeel Farooqui, MD, FAAAAI, FACAAI, Assistant Professor, Department of Medicine, Indiana University School of Medicine. “Enabling patients to track their inhaler use data, including frequency and inspiratory flow rates, each time they use their inhaler, can play a significant role in helping me have open, informed conversations with them about how best to manage their condition.”
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“The approval of a third product in the Digihaler™ portfolio is an incredibly exciting milestone for us,” said Sven Dethlefs, Executive Vice President, Global Marketing & Portfolio. “Our portfolio now includes a rescue treatment, a maintenance combination therapy, and now a maintenance monotherapy. All three of these digital inhalers with built-in sensors pair with companion mobile apps, allowing patients to track their inhaler use across multiple digital devices and have a better understanding of their condition. Patients may also choose to share this data with their healthcare providers.”
The approval of ArmonAir® Digihaler™ is based on the review of the supplemental new drug application (sNDA) submitted by Teva to the FDA. ArmonAir® Digihaler™ was approved in a low, medium and high dose: 55 mcg, 113 mcg and 232 mcg administered as one inhalation twice daily.
“Twenty-five million Americans are living with asthma1, and it’s important that they track their medication use and frequency to ensure they are managing the disease appropriately,” said Tonya Winders, President & CEO of the Allergy & Asthma Network. “Thanks to technological advancements like these, the ability to monitor this type of data for different types of asthma medications can help patients foster open conversations with their healthcare providers, in an effort to ensure their asthma is well-managed.”
The complete Digihaler™ portfolio is expected to become commercially available to patients later this year.