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Classified in: Science and technology, Covid-19 virus
Subject: Product/Service

Teva Announces Availability of ProAir® Digihaler® (albuterol sulfate 117 mcg) Inhalation Powder for Patients with Asthma and COPD


Teva Respiratory, LLC., a U.S. affiliate of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) today announced the launch of ProAir® Digihaler® (albuterol sulfate 117 mcg) Inhalation Powder, the first and only digital rescue inhaler indicated in patients four years or older for the treatment or prevention of bronchospasm who have reversible obstructive airway disease, and for prevention of exercise-induced bronchospasm (EIB). The device features built-in Bluetooth® Wireless Technology sensors, which connect to a companion mobile app and provide inhaler event information.

"The launch of ProAir® Digihaler® and its companion app provides a great opportunity for bringing a new digital health tool to asthma and COPD patients in the U.S.," said Brendan O'Grady, Executive Vice President, North America Commercial at Teva Pharmaceuticals. "We are especially proud to provide our first Digihaler® product at a time when digital health technology is growing and continues to transform patient care, since it will enable patients to electronically record and monitor their rescue inhaler use."

The ProAir® Digihaler® inhaler detects, records and stores objective inhaler event data, including timestamp and inhalation characteristics such as peak inspiratory flow. Patients are then able to view this data on the ProAir® Digihaler® app, which informs patients if their inhaler technique may need improvement. If desired, patients can share these data with their healthcare providers (HCPs) to help facilitate dialogue around the assessment and management of their condition and discuss if their inhaler technique may need improvement.

"It is our belief that ProAir® Digihaler® and the companion app will help address an unmet need for HCPs by providing objective rescue inhaler use data when managing their patients," said Sven Dethlefs, Executive Vice President, Global Marketing & Portfolio at Teva Pharmaceuticals. "Ultimately, this technology may help patients who use ProAir® Digihaler® and its accompanying app to have a better-informed dialogue with their HCP about their disease management and treatment decisions."

ProAir® Digihaler® was approved by the U.S. Food and Drug Administration (FDA) in December 2018 and is a part of Teva's Digihaler® portfolio, which also includes AirDuo® Digihaler® (fluticasone propionate and salmeterol) Inhalation Powder and ArmonAir® Digihaler® (fluticasone propionate) Inhalation Powder. AirDuo® Digihaler® is indicated for the maintenance treatment of asthma in patients 12 years of age and older and ArmonAir® Digihaler® is indicated for the maintenance treatment of asthma in patients 12 years and older. Both products are expected to become commercially available to patients in the coming months. Please view the Important Safety Information for these products below.

The Wholesale Acquisition Cost (WAC or "list price") for ProAir® Digihaler® is $146.67. Actual costs to individual patients and providers for ProAir® Digihaler® are anticipated to be lower than WAC because WAC does not account for additional rebates and discounts that may apply. Savings on out-of-pocket costs may vary depending on the patient's insurance payer and eligibility for participation in the assistance program. ProAir® Digihaler® is also supported by a co-pay card program. Patients can register for, and download, the card on ProAirDigihaler.com.

PROAIR® DIGIHALER® APPROVED USES

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 patients to take their medicine.

PROAIR® DIGIHALER® IMPORTANT SAFETY INFORMATION

Please read the full Prescribing Information for ProAir Digihaler.

AIRDUO® DIGIHALER® APPROVED USES

AIRDUO® DIGIHALER® IMPORTANT SAFETY INFORMATION

Please see full Prescribing Information for AirDuo Digihaler.

ARMONAIR® DIGIHALER® APPROVED USES

ArmonAir® Digihaler® (fluticasone propionate) inhalation powder is a prescription inhaled corticosteroid (ICS) medicine for the long-term treatment of asthma in patients 12 years and older.

ArmonAir Digihaler is not used to relieve sudden breathing problems from asthma and won't replace a rescue inhaler.

ArmonAir Digihaler contains a built-in electronic module that records and stores information about inhaler events. ArmonAir Digihaler may be used with, and transmits information to a mobile App. ArmonAir Digihaler does not need to be connected to the app in order for you to take your medicine.

ARMONAIR® DIGIHALERtm IMPORTANT SAFETY INFORMATION

Please see full Prescribing Information for ArmonAir Digihaler.

About Teva

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 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 re: the launch of ProAir® Digihaler® (albuterol sulfate 117 mcg) Inhalation Powder for Patients with Asthma and COPD, 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 Quarterly Report on Form 10-Q for the first quarter of 2020 and our Annual Report on Form 10-K for the year ended December 31, 2019, including in the sections captioned "Risk Factors" and "Forward Looking Statements." 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.

The Bluetooth® word mark and logos are registered trademarks owned by Bluetooth SIG, Inc. and any use of such marks by Teva Pharmaceutical Industries Ltd. is under license. Other trademarks and trade names are those of their respective owners.


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