Teva Announces FDA Approval of AirDuo? Digihaler? (fluticasone propionate 113 mcg and salmeterol 14 mcg) Inhalation Powder

發(fā)布時間： 2019-07-23 閱讀：1315次

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JERUSALEM and PARSIPPANY, N.J., July 15, 2019 ? Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) announced today that the U.S. Food and Drug Administration (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.

“We are thrilled to be able to expand our Digihaler? portfolio to now include a maintenance treatment,” said Tushar Shah, M.D., Global Head of Specialty Clinical Development at Teva Pharmaceuticals. “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 approval of AirDuo? Digihaler? is based on the review of the supplemental new drug application (sNDA) 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? was approved in a low, medium and high dose: 55/14 mcg, 113/14 mcg and 232/14 mcg administered as one inhalation twice daily. As a fixed dose combination asthma therapy containing an ICS and a LABA, AirDuo? Digihaler? contains the same active ingredients as Advair Diskus?, which is also approved in low, medium and high doses: 100/50 mcg, 250/50 mcg and 500/50 mcg.

“Even the most diligent asthma patients may not realize they are not following their treatment regimen, despite their best efforts,” said Dr. Nabeel Farooqui, MD, FAAAAI, FACAAI, Assistant Professor, Department of Medicine, Indiana University School of Medicine. “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 discussions with physicians. As a doctor, it’s exciting that my patients are able to share this type of information with me.”