Teva Pharmaceutical Industries said the FDA has approved its respiratory digital therapeutic ProAir® Digihaler™ (albuterol sulfate 117 mcg) inhalation powder as the first and only digital inhaler with built-in sensors and a companion mobile app designed to provide inhaler use information to people with asthma and COPD.

ProAir Digihaler is indicated for the treatment or prevention of bronchospasm in patients aged four years and older with reversible obstructive airway disease, as well as for prevention of exercise-induced bronchospasm (EIB) in patients aged four years and older.

“This approval marks a significant milestone not only for Teva, but for the respiratory community as it allows patients and their caregivers to better understand inhaler usage through digital technology,” Sven Dethlefs, EVP, global marketing & portfolio at Teva, said in a statement.

ProAir Digihaler combines a breath-activated, multi-dose dry powder inhaler with albuterol, the most widely used asthma rescue medication, with built-in sensors designed to detect when the inhaler is used as well as measure inspiratory flow.

Data on inhaler use is transmitted to the companion mobile app using Bluetooth® wireless technology, enabling patients to review their data, and if they choose, to share it with their healthcare professionals.

“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,” added Tushar Shah, M.D., Teva SVP, global specialty clinical development.

Teva said the ProAir Digihaler will be available in the new year through a small number of “Early Experience” Programs to be conducted in partnership with healthcare systems and in limited geographies, in order to gather real-world experience.

2020 National Launch

A national launch is planned for 2020, Teva added.

ProAir Digihaler is among examples of “digital therapeutics,” defined in an October report by the Digital Therapeutics Alliance industry consortium to include 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.”

“DTx products incorporate advanced technology best practices relating to design, clinical validation, usability, and data security. They are reviewed and cleared or approved by regulatory bodies as required to support product claims regarding risk, efficacy, and intended use,” according to the definition. “Digital therapeutics empower patients, healthcare providers, and payers with intelligent and accessible tools for addressing a wide range of conditions through high quality, safe, and effective data-driven interventions.”

According to “Digital Therapeutics Report 2018-2025,” a report whose release was announced Friday by ResearchandMarkets, investments in digital therapeutics stood at $179.6 billion at the end of 2016, and are projected to grow to $536.6 billion by the end of 2025.

The FDA’s approval of ProAir Digihaler was based on the review of a supplemental new drug application (sNDA) submitted 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,” stated Tonya Winders, president & CEO of the Allergy & Asthma Network. “This approval is a major step forward and is indicative of how medications are evolving through technological innovations.”

The approval of ProAir Digihaler comes nine months after the FDA granted 510(k) clearance for over-the-counter (OTC) sales of digital health company Adherium’s SmartinhalerTM sensor for AstraZeneca’s Symbicort® aerosol asthma inhaler.

Smartinhaler is a device installed onto a patient’s inhaler to monitor and promote asthma and COPD medication adherence as part of a self-management plan. Smartinhaler records the date and precise time the inhaler is used, automatically transmits that data to an app on the patient’s phone or tablet, and stores the history of patient medication usage patterns. According to Adherium, the sensor design includes three buttons that help patients easily access the audio visual-reminders, battery monitoring, and Bluetooth® wireless technology

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