The FDA has approved low, medium, and high dose versions of Teva’s AirDuo Digihaler fluticasone propionate/salmeterol digital DPI for the treatment of asthma, the company said. The inhaler should be available in the US sometime next year. AirDuo Respiclick has been approved by the FDA since January 2017 and was launched in the US in April of that year.
The Digihaler device includes flow rate and usage sensors that communicate with a mobile app via Bluetooth. Teva’s ProAir Digihaler albuterol smart DPI was approved by the FDA in December 2018.
Teva Pharmaceuticals Global Head of Specialty Clinical Development Tushar Shah said, “We are thrilled to be able to expand our Digihaler portfolio to now include a maintenance treatment. 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.”
Teva Executive VP, Global Marketing & Portfolio, Sven Dethlefs added, “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. This technology aims at delivering innovations through cloud-based services with the target to provide new insights to guide treatment choices for caregivers to help them improve outcomes for asthma patients.”
Read the Teva press release.
