According to Teva, the FDA has approved the company’s sNDA for ProAir Digihaler dry powder albuterol smart inhaler for the treatment or prevention of bronchospasm in patients aged 4 and over. The FDA initially approved Teva’s ProAir Respiclick albuterol DPI in 2015, and the agency approved ProAir Respiclick for pediatric use in 2016.
The company said that a limited number of ProAir Digihalers, which include sensors that send usage and inspiratory flow data to an app via Bluetooth, will be available in 2019 through some healthcare systems. A US-wide launch is set for 2020.
Teva Executive VP, Global Marketing & Portfolio, Sven Dethlefs said, “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. 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.”
Teva Pharmaceuticals Global Head of Specialty Clinical Development & Medical Affairs Tushar Shah commented, “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. 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.”
Read the Teva press release.
