FDA Approves First-Ever Inhaler with Built-in Sensor for Bronchospasm Management

Recently, the global generic drug giantTeva(Teva) stated that the products manufactured by its subsidiaryProAir DigihalerThe inhalation device has been approved by the U.S. Food and Drug Administration (FDA) approval, the device is an electronic inhalation device that can use sensors to connect to a companion mobile phone application, meeting the needs of patients with asthma and chronic obstructive pulmonary disease (COPD) patients' treatment needs. This is also the United StatesFDAThe first approved digital inhaler with a built-in sensor.

ProAir DigihalerThe inhalation device features built-in sensors that measure inspiratory flow and detect when the patient uses the inhaler. The patient’s health data and usage information are transmitted to a mobile application, allowing users to view their historical data at any time and share it with relevant healthcare professionals.

This time,FDAApproved TevaProAir DigihalerInhalation devices are indicated for the treatment or prevention of bronchospasm in patients with reversible obstructive airway disease, and for the prevention of exercise-induced bronchospasm.

President and Chief Executive Officer of the Allergy & Asthma Network, a U.S. nonprofit organizationTonya WindersIn a statement, it said, “Currently in the United States there are2500Millions of people suffer from asthma, and many of them use inhalers as part of their treatment regimen. Although significant progress has been made in the care of respiratory diseases such as asthma over the years, we know that many individuals still use their medications incorrectly, with errors in dosage or frequency. This time, the United StatesFDAApprovalProAir DigihalerInhalation devices are undoubtedly crucial for this patient population, as these digital devices can help patients track their inhaler usage and provide data that facilitates more collaborative asthma management. This approval is for asthma andCOPD“An important step forward in management, which also demonstrates how health management is advancing through technological innovation.”

Teva stated that, asFDAThe first approved inhaler with a built-in sensor,ProAir DigihalerBefore its official market launch, additional testing plans may still be required. The company stated,ProAir DigihalerInhalation devices will first be in2019provided to relevant patient populations through a series of early access programs annually; if these early access programs proceed smoothly, the company plans to2020to be launched across the United States at some point during the year.

Executive Vice President, Global Marketing and Portfolio, TevaSven Dethlefsstated, “This approval is not only a significant milestone for Teva, but also an important milestone for the global respiratory disease community. Teva deeply recognizes the importance of integrating digital technologies into patient care,”ProAir DigihalerApproval of the inhalation device can provide a competitive edge in this field. The digital technology embedded in the device provides and stores inhaler usage data for patients, which may help them discuss asthma orCOPDmanagement, to facilitate more informed discussions and clinical decision-making.”

Senior Vice President, Global Professional Clinical Development, Teva Pharmaceutical IndustriesTushar ShahThe doctor said, “Physicians are caring for their asthma andCOPDOne of the challenges faced by clinicians is determining whether their patients are using their inhaled medications correctly and in accordance with medical advice.ProAir DigihalerInhalation devices meticulously record user usage data, enabling physicians to review actual patient inhaler utilization data; this is precisely why such devices are so critical to physician-patient discussions.

(Compiled by Sina Medicine/Fan Dongdong)

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1、FDA approves Teva's digital COPD, asthma inhaler