Teva Respiratory, LLC., a U.S. affiliate of Teva Pharmaceutical Industries Ltd. announced the launch of AirDuo® Digihaler® (fluticasone propionate and salmeterol) inhalation powder and ArmonAir® Digihaler® (fluticasone propionate) inhalation powder, two digital maintenance inhalers for patients with asthma. AirDuo® Digihaler® is a prescription medicine used to control symptoms of asthma and to prevent symptoms such as wheezing in people 12 years of age and older. ArmonAir® Digihaler® is a prescription medicine for the long-term treatment of asthma in patients 12 years and older. AirDuo® Digihaler® and ArmonAir® Digihaler® are not used to relieve sudden breathing problems from asthma and will not replace the need for a rescue inhaler.
“Being able to now offer AirDuo® Digihaler® and ArmonAir® Digihaler® to patients is an exciting step forward for Teva, and one that we are extremely proud of,” said Brendan O’Grady, Executive Vice President, North America Commercial at Teva Pharmaceuticals. “With the launch of these two maintenance products, we’re now able to offer the full Digihaler® portfolio to patients, potentially allowing them to gain an even deeper understanding of their overall asthma treatment regimen due in part to the data collection capabilities of the Digihaler® portfolio of products.”
Both products contain built-in Bluetooth® Wireless Technology, which connects to a companion mobile app and provides data on inhaler use, which is recorded as an event when the cap is opened or a patient inhales. AirDuo® Digihaler® and ArmonAir® Digihaler® are part of Teva’s Digihaler® portfolio, which also includes ProAir® Digihaler®, the first and only digital rescue inhaler indicated in patients four years or older for the treatment or prevention of bronchospasm who have reversible obstructive airway disease, and for prevention of exercise-induced bronchospasm (EIB). All three products are now commercially available to patients by prescription. Please view the Important Safety Information for these products below.
“The launch of AirDuo® Digihaler® and ArmonAir® Digihaler® completes our portfolio of digitally connected inhalers and allows Teva to provide maintenance and rescue digital inhaler options to the U.S. respiratory community, especially in a time when digital health tools are more important than ever,” said Sven Dethlefs, Executive Vice President, Global Marketing & Portfolio at Teva Pharmaceuticals. “The full Digihaler® family is a major step forward for digital health technologies in helping to transform patient care, and we hope it will enable patients and their healthcare providers to better inform treatment decisions. For Teva, the Digihaler® launch is the starting point for new software-based innovations in respiratory, moving treatment options beyond new therapeutic entities.”
The AirDuo® Digihaler® and ArmonAir® Digihaler® inhalers automatically detect, record and store objective inhaler use data, including peak inspiratory flow. Both products have the ability to remind the patient how often the devices have been used, measure inspiratory flow rates and determine if inhalation technique may need improvement. This usage and inspiratory flow data are then directly sent to the Digihaler® app via Bluetooth® technology, giving patients the ability to share their data with healthcare providers (HCPs) if they choose to. Access to this data may allow HCPs to make more informed treatment decisions.
AirDuo® Digihaler® was approved by the U.S. Food and Drug Administration (FDA) in July 2019 in a low, medium and high dose: 55/14 mcg, 113/14 mcg and 232/14 mcg administered as one inhalation twice daily. ArmonAir® Digihaler® was approved by the FDA in February 2020 in a low, medium and high dose: 55 mcg, 113 mcg and 232 mcg administered as one inhalation twice daily.
“Until now, I have had to rely on my patients’ memory to share the details of their inhaler use habits with me – which, despite their best efforts, can be difficult and confusing. Being able to see my patients’ rescue and maintenance inhaler use data can help me assess if they are using their inhalers as prescribed,” said Dr. J. Allen Meadows, MD, FACAAI, Clinical Faculty, Alabama College of Osteopathic Medicine. “In addition, getting access into their inspiratory flow rates may also help me identify patients who might need coaching in inhaler technique improvement.”
The Wholesale Acquisition Cost (WAC or “list price”) for AirDuo® Digihaler® in the doses 55/14 mcg and 113/14 mcg is $399 and the WAC price for the 232/14 mcg dose is $449. The WAC price of ArmonAir® Digihaler® in the doses 55 mcg and 113 mcg is $239 and the WAC price for the 232 mcg dose is $299. Actual costs to individual patients and providers for both products are anticipated to be lower than WAC because WAC does not account for additional rebates and discounts that may apply. Savings on out-of-pocket costs may vary depending on the patient’s insurance payer and eligibility for participation in the assistance program.
Source: Teva Pharmaceuticals