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FDA approves first digital inhaler for asthma, COPD
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The FDA recently announced its approval of ProAir Digihaler for the management of asthma and COPD, according to a press release.
ProAir Digihaler (Teva Pharmaceutical Industries) is the first and only digital inhaler, according to the release. The breath-activated, multi-dose dry powder inhaler delivers 117 µg of albuterol, according to the release.
“There are 25 million Americans living with asthma, many of whom use inhalers as part of their treatment regimen,” Tonya Winders, president and CEO of the Allergy and Asthma Network, said in the release. “Despite advancements in care over the years, we know that many are using their rescue medications incorrectly or too often.”
The digital inhaler has built-in sensors that detect inhaler use and measure inspiratory flow, according to the release. The data is sent to a companion mobile app using Bluetooth Wireless Technology for patients and health care professionals to review over time, according to the release.
The FDA approval is important because it will allow patients to work more closely with their health care providers on their asthma and COPD management, Winders noted.
The inhaler is indicated in patients aged 4 years or older for the treatment or prevention of bronchospasm in reversible obstructive airway disease and for the prevention of exercise-induced bronchospasm, according to the release.
“This approval marks a significant milestone ... for the respiratory community as it allows patients and their caregivers to better understand inhaler usage through digital technology,” Sven Dethlefs, executive VP of Global Marketing and Portfolio at Teva Pharmaceutical Industries, said in a release. “Teva recognizes the importance of integrating technology into patient care, and we are very proud to lead the way with the approval of ProAir Digihaler.”
The digital inhaler will be available this year through a limited amount of “Early Experience” Programs, with a national release expected in 2020, according to the release.
“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, global head of Specialty Clinical Development and Medical Affairs at Teva Pharmaceuticals, said in the 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.”