FDA Approves First Digital Inhaler With Tracking App


The US Food and Drug Administration (FDA) has approved the first and only digital inhaler with a built-in sensor that connects to a companion mobile application that can monitor usage as well as strength of the user’s inhalation.

The ProAir Digihaler, from Teva Pharmaceutical Industries, contains albuterol sulfate 117 µg powder for inhalation.

The new inhaler is approved for use in people aged 4 years and older to treat or prevent bronchospasm in individuals with reversible obstructive airway disease and to prevent exercise-induced bronchospasm. The approval is based on review of a supplemental new drug application submitted by Teva to the FDA.

“The digital technology built into ProAir Digihaler provides patients with data on their inhaler use, which may help them to have a more informed dialogue with their healthcare provider regarding their asthma or COPD [chronic obstructive pulmonary disease] management,” Sven Dethlefs, Teva executive vice president, global marketing and portfolio, said in a news release.

“There are 25 million Americans living with asthma, many of whom use inhalers as part of their treatment regimen. Despite advancements in care over the years, we know that many are using their rescue medications incorrectly or too often,” Tonya Winders, president and CEO of the Allergy and Asthma Network, said in the release.

“The FDA approval of ProAir Digihaler is significant because it may help patients track their inhaler usage and provide data that can be used to work more closely with their HCPs [healthcare providers] on their asthma management. This approval is a major step forward and is indicative of how medications are evolving through technological innovations,” Winders said.

Teva said the ProAir Digihaler will be available in 2019 through a small number of “early experience” programs, which will be conducted in partnership with healthcare systems in limited geographic areas, in order to gather real-world experience.

A national launch is planned for 2020.

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