Teva’s ProAir Digihaler for Asthma, COPD gets US FDA Approval.
Source: Teva Pharmaceuticals Jan 01, 2019 5 years, 10 months, 1 week, 7 hours, 53 minutes ago
The FDA has approved the first inhaler with built-in monitoring sensors to track medication adherence for asthma and COPD patients, according to Teva Pharmaceutical Industries Ltd. The ProAir Digihaler (albuterol sulfate 117 mcg) inhalation powder is equipped with built-in sensors that connect via Bluetooth to a companion mobile application, which stores data.
Teva's ProAir Digihaler
The device 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.”
The approval 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, MD, Global Head of Specialty Clinical Development & Medical Affairs 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.
