The ProAir Digihaler, from Teva, will reach the US markets widescale in 2020 after receiving FDA approval.
The US Food and Drug Administration (FDA) approved the first and only mobile app-friendly digital inhaler with built-in sensors for patients with asthma and chronic obstructive pulmonary disease (COPD).
The digital inhaler, albuterol sulfate 117 mcg inhalation powder (ProAir Digihaler), has been indicated for the treatment and prevention of bronchospasm in patients aged 4 years and older with reversible obstructive airway disease (OAD), as well as for the prevention of exercise-induced bronchospasm (EIB) in similarly aged patients.
Teva Pharmaceutical’s new device received the FDA approval on December 21—just prior to the start of the federal government shutdown. The company now plans a national launch of the tech-savvy inhaler for 2020.
The ProAir Digihaler is equipped with digital technology that provides patients with data on their inhaler use—intended to help improve dialogue between patients and physicians on the former’s OAD management and care.
“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, Executive Vice President of Teva’s Global Marketing & Portfolio, said in a statement.
AOD inhaler adherence and proper use has been a continued area of focus for clinicians and investigators alike. Last year, Sonali Bose, MD, an assistant professor at the Icahn School of Medicine, told MD Magazine® that adherence and proper use issues have become so prevalent that there’s belief improving both practices would result in downstream benefits for AOD care.
“A lot of what we thought about previously as being severe asthma actually ends up being asthma that is difficult to treat because of these issues in the way patients have been taking their medications—not only in terms of their inhaler technique, but also in terms of their adherence,” Bose said.
In a submitted column to MD Mag on the importance of correct inhaler use, Tonya Winders, MBA, president and chief executive officer of the Allergy & Asthma Network, advocated for a review of inhaler technique at each patient-physician appointment.
“(Healthcare providers), in partnerships with their patients, can demonstrate optimal inhaler technique to empower their patients and families to strive for an increased and robust lifestyle,” Winders wrote.
The new Teva digital inhaler uses built-in sensors which detect inhaler use and measure inspiratory flow. Such data is sent to a companion mobile app via Bluetooth, allowing patients to review and share data over the duration of care.
The administered therapy from the inhaler is a breath-activated, multi-dose dry powder albuterol—the most commonly used asthma therapy. Its approval was based on the review of a supplemental new drug application (sNDA). The availability of the inhaler through 2019 will be based on a limited number of “Early Experience” program partners, which will allow healthcare systems in certain regions of the country to contribute to the first round of real-world application analysis.
In a statement accompanying the approval, Winders noted the benefit of a technological advancement in a field currently occupied by 25 million US patients—most with a history of difficulty properly treating their OAD.
“This approval is a major step forward and is indicative of how medications are evolving through technological innovations,” Winders said.