Teva Industries, Ltd. has received approval for its AirDuo® Digihaler™ (fluticasone propionate 113 mcg and salmeterol 14 mcg) Inhalation Powder, a combination therapy digital inhaler that connects to a mobile app to provide information on inhaler use to people with asthma. The Digihaler™ is indicated for the treatment of asthma in patients aged 12 years and older. The system is not used to relieve sudden breathing problems and does not replace a rescue inhaler.
The inhaler enables patients to track how frequently they are using their inhalers. This may help inform conversations with their doctors about treatment adherence and correct technique.
The inhaler contains built-in sensors that detect when it is being used and measure inspiratory flow rates. The data are then sent to a companion mobile app, which allows patients to review their data over time and share it with their healthcare providers.
The approval 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 decrease inflammation in the lungs, and salmeterol, a long acting beta2 adrenergic agonist (LABA), which enables the muscles around the airways to remain relaxed, and prevent symptoms.
When used alone, LABA medicines such as salmeterol increase the risk of hospitalization and death from asthma problems. AirDuo Digihaler contains an ICS and a LABA, but when those are used together, there is no significant increased risk in hospitalizations and death from asthma problems.
AirDuo® Digihaler™ was approved in low, medium, and high doses: 55/14 mcg, 113/14 mcg, and 232/14 mcg administered as one inhalation twice daily. The inhaler is expected to be available to patients by prescription in 2020.
Among the serious side effects cause by AirDuo are thrush; immunosuppression; reduced adrenal function; sudden breathing problems; serious allergic reactions; increased blood pressure, fast/irregular heartbeat, or chest pain; tremor or nervousness; osteoporosis; slowed growth in children; glaucoma and cataracts; and changes in laboratory blood values.
Common side effects include nasopharyngitis; thrush in throat or mouth; back pain; headache; and cough.
Source: BioSpace, July 15, 2019