FDA OKs mHealth Device, App for Asthma, COPD Care Management
The FDA has approved an mHealth platform, consisting of a digital inhaler and companion mHealth app, designed to help those living with asthma and COPD manage their medication use and collaborate with care providers.
The ProAir Digihaler, developed by Teva Pharmaceutical, is approved to treat or prevent bronchospasm in people ages 4 and older with reversible obstructive airway disease, as well as to prevent exercise-induced bronchospasm. It consists of a breath-activated, multi-dose inhaler that dispenses albuterol, as well as sensors that track inhaler use and inspiratory flow. Data tracked by the sensors is collected on the mHealth app.
The market for digital health inhalers and respiratory devices is growing, as evidenced by the planned $225 million acquisition of Propeller Health by ResMed. These and other companies are developing mHealth platforms that not only enable consumers to track their own care, but share data with care providers for better care management and coordination.
“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,” Tushar Shah, MD, Teva’s Senior Vice President of Global Specialty Clinical Development, said in a press release. “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.”
“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 incorrectly2 or too often,” added Tonya Winders, President & CEO of the Allergy & Asthma Network, 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 on their asthma management. This approval is a major step forward and is indicative of how medications are evolving through technological innovations.”
The connected health device is part of a growing digital therapeutics landscape aimed at combining technology with medicine to improve medication management, particularly in patients with chronic conditions. The Digital Therapeutics Alliance, established roughly one year ago, defines the field as treatments that “deliver evidence-based therapeutic interventions to patients that are driven by high-quality software programs to prevent, manage, or treat a medical disorder or disease. They are used independently or in concert with medications, devices, or other therapies to optimize patient care and health outcomes.”
Earlier this month, California-based Dignity Health noted that its digital therapeutic platform for asthma patients, which uses Propeller Health’s mHealth platform, helped to reduce emergency room visits and hospitalizations by more than 50 percent.
“This is a perfect example of the positive effect a novel technology can have in helping patients manage a chronic condition,” Rich Roth, Dignity Health’s chief strategic innovation officer, said. “When the sensor communicates more data to physicians, and patients have greater insight into their asthma triggers, outcomes improve and everyone wins.”
Teva officials said the ProAir Digihaler will be available in 2019 through “early experience” partnerships with healthcare systems. A national launch is planned for 2020.