Teva's ProAir Digihaler breezes into U.S. market

Teva plans to round out its U.S. Digihaler launch with its AirDuo and ArmonAir devices later this year. (Geber86/GettyImages).

Digital health is paving the way for novel doctor-patient communication in the industry, and with the COVID-19 pandemic halting routine hospital visits across the U.S.—and posing a greater risk to patients with existing respiratory conditions—Teva Pharmaceuticals has broken into the digital asthma market at a particularly important time. 

In July, Teva announced the launch of its ProAir Digihaler in the U.S., with two other stateside rollouts from its smart inhaler portfolio on the horizon for 2020.

Approved for use in reversible obstructive airway diseases like asthma and chronic obstructive pulmonary disease (COPD) in patients 4 and older, the powdered albuterol dispenser connects wirelessly to a companion app that tracks event data and offers patient feedback, too. 

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The Digihaler provides timestamps when used and records inhalation characteristics like inspiratory flow rate—the amount one needs to breathe in to draw medication out of the inhaler and into the lungs. The Digihaler is also approved for use in exercise-induced bronchospasm. 

Patients can view their event data through the ProAir companion app, which provides tips to improve inhaler technique and offers medication reminders, if they choose. They can also transmit data directly to their doctors to maintain a running dialogue about condition management and treatment improvement—a particular boon now that digital health is keeping patients and healthcare providers connected amid COVID-19 hospital slowdowns. 

“We are especially proud to provide our first Digihaler product at a time when digital health technology is growing and continues to transform patient care, since it will enable patients to electronically record and monitor their rescue inhaler use," Brendan O'Grady, executive vice president of Teva's North American commercial operations, said. 

RELATED: AstraZeneca touts triplet inhaler Breztri's COPD win ahead of key FDA decision

Now, 24.7 million Americans are currently living with asthma, the CDC estimates, many of whom use inhalers as part of their treatment. An additional 12.8 million adults suffer from chronic bronchitis or emphysema, and chronic respiratory diseases accounted for 160,201 U.S. deaths in 2017, the public health agency found.

While albuterol sulfate, the powdered medication included in Teva's ProAir Digihaler, is already available, the new data-driven capabilities of its Digihaler portfolio could drive adoption by respiratory clinicians eager to get their hands on patient data. 

“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, M.D., Teva's global head of specialty clinical development and medical affairs, said. “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.”

RELATED: AstraZeneca's 3-in-1 COPD inhaler Breztri gets FDA green light to play catch-up with GSK's Trelegy

Teva first nabbed U.S. approval for its ProAir Digihaler in late 2018. At the time, a study suggested that the digitally-connected inhaler could use patient data to potentially predict future asthma events. Meanwhile, Perrigo and its manufacturing partner Catalent forged ahead on a four-year-long odyssey to churn out their own generic version of Teva's base ProAir inhaler, finally grabbing a green light on their fourth attempt in early 2020. 

But Teva's trio of Digihaler approvals could provide a salve for that generic competition, and the Israeli pharma isn't stopping with its ProAir smart inhaler rollout this year either. 

Midway through 2019, the company got the thumbs up for its AirDuo Digihaler for combination maintenance, followed by an early 2020 nod for its monotherapy maintenance ArmonAir smart inhaler. While Teva's ProAir Digihaler leads the charge into the U.S. digital health market, AirDuo and ArmonAir are expected to round out the U.S. Digihaler launches by year-end, Teva said. 

Available by prescription, ProAir Digihaler bears a U.S. list price of $146.67. 

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