New Launches Complete Teva’s Digital Inhaler Portfolio

Teva Respiratory’s launch last week of two digital maintenance inhalers (the AirDuo and ArmonAir Digihalers) for patients with asthma completes the company’s Digihaler portfolio, which was introduced with the ProAir Digihaler, the first and only digital rescue inhaler indicated in patients four years or older for the treatment or prevention of bronchospasm who have reversible obstructive airway disease, and for prevention of exercise-induced bronchospasm (EIB). Like the ProAir, the AirDuo and ArmonAir Digihalers contain built-in Bluetooth wireless technology, which connect to a companion mobile app and provide data on inhaler use, which is recorded as an event when the cap is opened or when a patient inhales.

The AirDuo and ArmonAir inhalers automatically detect, record and store objective inhaler use data, including peak inspiratory flow. Both products have the ability to remind the patient how often the devices have been used, measure inspiratory flow rates and determine if inhalation technique may need improvement. This usage and inspiratory flow data are then directly sent to the Digihaler app via Bluetooth technology, giving patients the ability to share their data with healthcare providers (HCPs) if they choose to. Access to this data may allow HCPs to make more informed treatment decisions.

Speaking to Pharm Exec, Sven Dethlefs, Executive Vice President, Global Marketing & Portfolio at Teva Pharmaceuticals, said, “I believe that this technology will lead to a revolution in asthma treatment. Until now, physicians have been unable to answer the key question: what happens when you prescribe an inhaler and the patient takes it home? What physicians can do with Teva’s digital inhalers is go to our cloud application and look at how the patients are actually using the inhaler. If the data reveals any problems, the physician can call the patient back for another consultation."

Expanding the digital product pipeline

Achieving FDA approvals for the Digihaler, the app and the surrounding software was a complicated process, but it has potentially smoothed the path for more digitally integrated products from Teva. The company had to work with three separate FDA departments, treating the approval exercise more as a “co-development process.” Dethlefs explains, “When you combine a pharmaceutical inhaler and a software system in one product, it becomes an FDA-regulated combination product. That has consequences for the software development. You have to think about documenting actions, you have to consider notifications, and we had many long discussions with the FDA around notifying patients about the data the inhaler is able to capture.”

Adds Dethlefs, “Having invested an enormous amount of resources to get the FDA approval, we now have some very useful insights into how to work with the Agency on software applications. We decided that, once we launched this technology and made it successful, we would then migrate it to other disease areas, namely CNS. We have some great ideas about where we could generate value for CNS patients with digitally integrated technologies.”