Teva Pharmaceutical Industries Ltd. announced that the U.S. Food and Drug Administration (FDA) has approved ProAir Digihaler (albuterol sulfate 117 mcg) inhalation powder, the first and only digital inhaler with built-in sensors which connects to a companion mobile application and provides inhaler use information to people with asthma and COPD.
ProAir Digihaler is indicated for the treatment or prevention of bronchospasm in patients aged four years and older with reversible obstructive airway disease, and for prevention of exercise-induced bronchospasm (EIB) in patients aged four years and older.
It contains built-in sensors that detect when the inhaler is used and measure inspiratory flow. This inhaler-use data is then sent to the companion mobile app using Bluetooth wireless technology so patients can review their data over time, and if desired, share it with their healthcare professionals.
The approval is based on the review of a supplemental new drug application (sNDA) submitted by Teva to the FDA. ProAir Digihaler combines a breath-activated, multi-dose dry powder inhaler with albuterol, the most widely used asthma rescue medication, with a built-in electronic module and a companion mobile app.
It will be available in 2019 through a small number of “Early Experience” Programs, which will be conducted in partnership with healthcare systems and in limited geographies, in order to gather real-world experience, according to Teva. A national launch is planned for 2020.
(Source: Teva Pharmaceutical Industries Ltd.)