15 July 2019 - The first digital maintenance asthma inhaler therapy with integrated sensors joins Teva’s digital rescue inhaler therapy to provide patients with technology to track treatment use.

Teva Pharmaceutical Industries announced today that the U.S. FDA has approved AirDuo Digihaler (fluticasone propionate 113 mcg and salmeterol 14 mcg) inhalation powder, a combination therapy digital inhaler with built-in sensors that connects to a companion mobile application to provide information on inhaler use to people with asthma. AirDuo Digihaler is indicated for the treatment of asthma in patients aged 12 years and older. AirDuo Digihaler is not used to relieve sudden breathing problems and won’t replace a rescue inhaler.

The approval of AirDuo Digihaler is based on the review of the supplemental new drug application submitted by Teva to the FDA. AirDuo Digihaler combines a breath-actuated, multi-dose dry powder inhaler with fluticasone propionate, an inhaled corticosteroid (ICS) medicine that may help to decrease inflammation in the lungs, which can lead to breathing problems, and salmeterol, a long acting beta2 adrenergic agonist (LABA), which helps the muscles around the airways in the lungs stay relaxed in order to prevent symptoms. AirDuo Digihaler contains salmeterol. LABA medicines such as salmeterol when used alone increase the risk of hospitalisations and death from asthma problems. AirDuo Digihaler contains an ICS and a LABA. When an ICS and a LABA are used together, there is not a significant increased risk in hospitalisations and death from asthma problems.

Read Teva Pharmaceuticals press release