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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
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.”
Like ProAir® Digihaler™ (albuterol sulfate 117 mcg) inhalation powder, indicated for the treatment or prevention of bronchospasm in patients aged four years and older with reversible obstructive airway disease, and for prevention of exercise-induced bronchospasm (EIB) in patients four years and older, AirDuo® Digihaler™ contains built-in sensors that detect when the inhaler is used and measure inspiratory flow rates. This data is then sent to a companion mobile app using Bluetooth® Wireless Technology so that patients can review their data over time, and if desired, share it with their healthcare providers. Patients can also schedule reminders on their smartphone to take their AirDuo® Digihaler™ as prescribed.
“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.”
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™ contains salmeterol. LABA medicines such as salmeterol when used alone increase the risk of hospitalizations 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 hospitalizations and death from asthma problems.
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.
“For the 25 million Americans living with asthma1, advancements like this one are important and could help patients track their inhaler use and frequency,” said Tonya Winders, President & CEO of the Allergy & Asthma Network. “Allowing patients access to both their rescue and maintenance inhaler use information on their smartphones 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™,” said Sven Dethlefs, Executive Vice President, Global Marketing & Portfolio. “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.”
AirDuo® Digihaler™ is expected to become commercially available to patients by prescription in 2020. For more information, visit www.AirDuoDigihaler.com.
AIRDUO® DIGIHALER™ APPROVED USES
AirDuo Digihaler contains a built-in electronic module that records and stores information about inhaler events. AirDuo Digihaler may be used with, and transmits information to, a mobile App.
AirDuo Digihaler does not need to be connected to the app in order for you to take your medicine.
AIRDUO® DIGIHALER™ IMPORTANT SAFETY INFORMATION
Please see full Prescribing Information for AirDuo Digihaler.
ProAir® Digihaler™ (albuterol sulfate) Inhalation Powder is a prescription medicine used in people 4 years of age and older to:
ProAir Digihaler contains a built-in electronic module that detects, records and stores inhaler event information. ProAir Digihaler may be used with, and transmits information to, a mobile app. ProAir Digihaler does not need to be connected to the mobile app in order for you to take your medicine.
Please read the full Prescribing Information.
Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) has been developing and producing medicines to improve people’s lives for more than a century. We are a global leader in generic and specialty medicines with a portfolio consisting of over 3,500 different products in nearly every therapeutic area. Around 200 million people around the world take a Teva medicine every day and are served by one of the largest and most complex supply chains in the pharmaceutical industry. Along with our established presence in generics, we have significant innovative research and operations supporting our growing portfolio of specialty and biopharmaceutical products. Learn more at www.tevapharm.com
Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 regarding AirDuo® Digihaler, which are based on management’s current beliefs and expectations and are subject to substantial risks and uncertainties, both known and unknown, that could cause our future results, performance or achievements to differ significantly from that expressed or implied by such forward-looking statements. Important factors that could cause or contribute to such differences include risks relating to:
and other factors discussed in our Annual Report on Form 10-K for the year ended December 31, 2018, including the sections thereof captioned "Risk Factors." Forward-looking statements speak only as of the date on which they are made, and we assume no obligation to update or revise any forward-looking statements or other information contained herein, whether as a result of new information, future events or otherwise. You are cautioned not to put undue reliance on these forward-looking statements.
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