Teva Pharmaceutical Industries Ltd.'s ProAir Digihaler became the first digital inhaler to be approved by the U.S. Food and Drug Administration to treat a type of asthma in children and adults.
The Israeli pharmaceutical giant said the product was approved to treat or prevent bronchospasm in patients 4 years and older with reversible obstructive airway disease and for preventing exercise-induced bronchospasm in patients 4 years and older.
Bronchospasm is a condition in which the muscles lining the airways in the lungs tighten and limit the amount of air in the lungs. About 25 million Americans have asthma, and many of them use inhalers as part of their treatment regimen, said the company.
Teva said the ProAir Digihaler inhalation powder is the first and only digital inhaler with built-in sensors that connect to a mobile application and provide inhaler-use information to people with asthma and chronic obstructive pulmonary disease.
ProAir Digihaler is an enhancement to the original ProAir, which was approved for the same use, but with a built-in electronic module and a companion mobile application.
Teva said the product will be available in 2019 through an "early experience" program that will be conducted in partnership with healthcare systems and in limited geographies.