Teva's ProAir Digihaler gains FDA approval, marking first digital inhaler with built-in sensors

Teva announced Friday that the FDA approved its ProAir Digihaler (albuterol sulfate) inhalation powder, "the first and only digital inhaler with built-in sensors which connects to a companion mobile application." Sven Dethlefs, executive vice president of global marketing and portfolio, remarked that "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 [chronic obstructive pulmonary disease] management."

The product is indicated to treat or prevent bronchospasm in patients aged four years and older with reversible obstructive airway disease, as well as to prevent exercise-induced bronchospasm in patients at least four years of age.

According to Teva, ProAir Digihaler combines a breath-activated, multi-dose dry powder inhaler with the asthma rescue medication albuterol with a built-in electronic module and a companion mobile app. The built-in sensors detect when the device is used and measure inspiratory flow. Meanwhile, inhaler-use data is sent via Bluetooth to the companion mobile app "so patients can review their data over time, and if desired, share it with their healthcare professionals," the company said.

Teva added that the inhaler will be available in 2019 through a small number of early experience programmes, with a national launch planned for 2020.