Teva's digital inhaler cleared by FDA

The prescription device detects each use and records it to a paired mobile app.
By Dave Muoio
03:47 pm

Jerusalem-based Teva Pharmaceuticals’ sensor-packed, app-connected digital inhaler has recently received marketing approval from the US FDA, according to a release from the company. The device will first become available next year through a “small number” of healthcare system pilot partnerships, with a full national launch currently planned for 2020.

Teva’s ProAir Digihaler is indicated for the prevention and treatment of bronchospasm among patients aged four years or older with reversible obstructive airway diseases such as asthma or COPD, as well as for the prevention of exercise-induced bronchospasm (EIB) among this same group.

The prescription digital albuterol dispenser houses a built-in module that detects and measures each use, and sends the recorded information to a Bluetooth-connected mobile app. With this, patients can review their inhaler usage and share the data with their doctor.

Why it matters

According to 2016 data from the CDC, roughly 26.5 million adults and children living in the US have asthma, and approximately 1.7 million emergency department visits with asthma as the primary diagnosis occurred in 2015. Easily recording inhaler use with the device not only helps patients and providers monitor adherence, but correct any errors when dispensing treatment.

“One of the challenges physicians are faced with in caring for their asthma and COPD patients is knowing if their patients are using their inhaled medication as they should. That’s what makes a product like this so important to doctor-patient discussions,” Dr. Tushar Shah, SVP of global specialty clinical development at Teva Pharmaceuticals, said in a statement. “Offering a tool that enables doctors to see data on their patients’ inhaler usage will allow them to have more productive conversations about identifying issues and how to manage their illness.”

What’s the trend

This month's approval comes a bit over three years after Teva announced its purchase of Gecko Health Innovations, a Cambridge, Massachusetts-based maker of smart inhalers. At the time, Gecko's leading product was CareTRx, a platform for chronic respiratory disease management that combined a connected sensor device, a data analytics platform, an accessible user interface and behavioral triggers to help asthma and COPD patients manage their condition.

Currently the digital inhaler market is led by Adherium and Propeller Health. This year the former received prescription and over-the-counter FDA clearances for its Hailie (formerly Smartinhaler) sensors for a variety of inhaled medication dispensers. Propeller, on the other hand, was acquired earlier this month by fellow digital respiratory health company ResMed for $225 million.

On the record

“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 & Asthma Network, said in a statement provided by Teva. “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 on their asthma management. This approval is a major step forward and is indicative of how medications are evolving through technological innovations.”


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