Teva (NYSE:TEVA) yesterday said that it received FDA approval for its AirDuo Digihaler Inhalation Powder.
The Israel-based company’s AirDuo Digihaler is a combination therapy digital inhaler with built-in sensors that can connect to a smartphone application, indicated to treat asthma in people 12 years and older.. It delivers a multi-dose dry powder of 113mcg of fluticasone propionate and 14 mcg of salmeterol.
“We are thrilled to be able to expand our Digihaler portfolio to now include a maintenance treatment,” global head of specialty clinical development Tushar Shah said in a press release. “With this approval, patients can now track how frequently they are using their inhalers. Granting patients the ability to track their maintenance inhaler use may help inform conversations with their doctors about treatment adherence and proper technique.”
The AirDuo Digihaler features built-in sensors that can detect when the inhaler is used and measure inspiratory flow rates. The data from the sensors is sent to its accompanying smartphone application via Bluetooth. Users can then review data over time and have the option to share with healthcare providers. The smartphone app can also send reminders to take the AirDuo Digihaler as prescribed.
“Even the most diligent asthma patients may not realize they are not following their treatment regimen, despite their best effort,” assistant professor in the department of medicine at the Indiana University School of Medicine Nabeel Farooqui said. “The ability to now measure their inspiratory flow rates and track their maintenance medication use, as well as the frequency with which they use their inhaler, may provide important data and insights to help inform treatment discussion with physicians. As a doctor, it’s exciting that my patients are able to share this type of information with me.”
Teva Pharmaceutical’s AirDuo Digihaler was approved in 55/14 mcg, 113/14 mcg and 232/14 mcg doses that are administered as one inhalation twice a day.
“For the 25 million Americans living with asthma, advancements like this one are important and could help patients track their inhaler use and frequency,” Tonya Winder, president and CEO of the Allergy & Asthma Network, said. “Allowing patients access to both their rescue and maintenance inhaler use information on their smartphone is a promising step towards potentially fostering greater discussions about asthma management.”
“The approval of AirDuo Digihaler is an important step for Teva and the respiratory community to create a technology platform for use in asthma management along with the previously-approved ProAir Digihaler,” executive VP of global marketing and portfolio Sven Dethlefs said. “This technology aims at delivering innovations through could-based services with the target to provide new insights to guide treatment choices for caregivers to help them improve outcomes for asthma patients.”