Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) announced today that the U.S. Food and Drug Administration (FDA) has approved ProAir® Digihaler™ (albuterol sulfate 117 mcg) inhalation powder, the first and only digital inhaler with built-in sensors which connects to a companion mobile application and provides 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, and 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,” said Sven Dethlefs, Executive Vice President, Global Marketing & Portfolio. “Teva recognizes the importance of integrating technology into patient care, and we are very proud to lead the way with the approval of ProAir® Digihaler™. The digital technology built into ProAir® Digihaler™ provides patients with data on their inhaler use, which may help them to have a more informed dialogue with their healthcare provider regarding their asthma or COPD management.”

ProAir® Digihaler™ contains built-in sensors that detect when the inhaler is used and measure inspiratory flow. This inhaler-use data is then sent to the companion mobile app using Bluetooth® Wireless Technology so patients can review their data over time, and if desired, share it with their healthcare professionals.

“There are 25 million Americans living with asthma1, many of whom use inhalers as part of their treatment regimen. Despite advancements in care over the years, we know that many are using their rescue medications incorrectly2 or too often3,” said Tonya Winders, President & CEO of the Allergy & Asthma Network. “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. This approval is a major step forward and is indicative of how medications are evolving through technological innovations.”

The approval of ProAir® Digihaler™ is based on the review of a supplemental new drug application (sNDA) submitted by Teva to the FDA. ProAir® Digihaler™ combines a breath-activated, multi-dose dry powder inhaler with albuterol, the most widely used asthma rescue medication, with a built-in electronic module and a companion mobile app.

“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,” said Tushar Shah, M.D., Senior Vice President, Global Specialty Clinical Development at Teva Pharmaceuticals. “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.”

ProAir® Digihaler™ will be available in 2019 through a small number of “Early Experience” Programs, which will be conducted in partnership with healthcare systems and in limited geographies, in order to gather real-world experience. A national launch is planned for 2020. For more information, visit www.ProAirDigihaler.com.

About Teva

Teva Pharmaceutical Industries Ltd. is a global leader in generic medicines, with innovative treatments in select areas, including CNS, pain and respiratory. We deliver high-quality generic products and medicines in nearly every therapeutic area to address unmet patient needs. We have an established presence in generics, specialty, OTC and API, building on more than a century-old legacy, with a fully integrated R&D function, strong operational base and global infrastructure and scale. We strive to act in a socially and environmentally responsible way. Headquartered in Israel, with production and research facilities around the globe, we employ 45,000 professionals, committed to improving the lives of millions of patients. Learn more at www.tevapharm.com.

Source – Businesswire https://www.businesswire.com/news/home/20181221005554/en/Teva-Announces-FDA-Approval-Digital-Inhaler-Built-In