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TEL AVIV, Israel & PARSIPPANY, N.J.--(BUSINESS WIRE)--Nov 7, 2022--
Teva Pharmaceuticals USA, Inc., a U.S. affiliate of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA), today announced that new findings from the CONNECT clinical trial program assessing the use of the Digihaler System compared to standard of care (SoC) in asthma management will be presented at the American College of Allergy, Asthma & Immunology (ACAAI) 2022 Annual Scientific meeting, being held November 10-14 in Louisville, Kentucky.
The data will be featured in six posters, three of which will highlight results from the CONNECT1 clinical trial evaluating the ProAir ® Digihaler (albuterol sulfate) inhalation powder with a built-in electronic sensor in asthma management versus SoC. Three additional posters will share the first data from the CONNECT2 clinical trial assessing the joint use of the ProAir Digihaler and the AirDuo ® Digihaler (fluticasone propionate and salmeterol) inhalation powder with a built-in sensor in asthma management versus SoC.
“We are looking forward to presenting six abstracts from our novel CONNECT clinical program assessing the use of the Digihaler System in asthma management and the potential impact of these digital health tools on patient-provider interactions, adherence over time, inhaler technique and frequency of SABA use,” said Randall Brown, MD MPH, Global Lead, Digital Health, Immunology and Respiratory Medical Affairs at Teva. “This is the first clinical trial program to evaluate the Digihaler System and its potential to support asthma management for patients with uncontrolled asthma compared to standard of care.”
The Digihaler is a digital health system comprised of an electronic multidose dry powder smart inhaler, connected app, Digital Health Platform cloud solution and dashboard that tracks reliever inhaler usage and inhalation quality as measured by inspiratory flow to aid in clinical decision-making. As per the U.S. Food and Drug Administration (FDA) approved label, there is no evidence that the use of the app leads to improved clinical outcomes, including safety and efficacy.
CONNECT1
Initial findings from the CONNECT1 trial were recently presented at the European Respiratory Society (ERS) International Congress 2022, highlighting the impact of the ProAir Digihaler System on asthma management compared to standard of care (SoC), and the full CONNECT1 results were published in the Journal of Allergy and Clinical Immunology: In Practice following the ERS presentations.
The three CONNECT1 data sets that will be presented at ACAAI will highlight:
CONNECT2
The CONNECT2 trial was conducted to assess the role of both the ProAir and AirDuo Digihalers in the treatment of asthma. CONNECT2 was a 24-week open-label, multicenter, randomized, parallel group study that evaluated the ProAir Digihaler and AirDuo Digihaler and their impact on asthma management compared to SoC in 427 patients with asthma. Participants in the SoC group continued treatment with their current SoC asthma maintenance and reliever medications.
The three CONNECT2 data sets that will be presented at ACAAI explore:
These poster presentations can be accessed by registering for the meeting.
Teva-sponsored data to be presented includes:
#P097 Effectiveness Of A Maintenance and Reliever Digital System To Improve Asthma Control (CONNECT2)
Session: TBC
Date/Time: Friday, November 11 th, 3:45 PM – 4:00 PM
#P098 Data From A Maintenance And Reliever Digital System Support Patient–Clinician Interactions In Asthma (CONNECT2)
Session: TBC
Date/Time: Friday, November 11 th, 4:00 PM – 4:15 PM
#P100 Objective Measurement Of Adherence To Asthma Treatment With A Maintenance and Reliever Digital System (CONNECT2)
Session: TBC
Date/Time: Friday, November 11 th, 4:15 PM – 4:30 PM
#P096 Short-acting Beta 2 -agonist Use Reduction Among Patients With Uncontrolled Asthma Using A Reliever Digital System (CONNECT1)
Session: TBC
Date/Time: Friday, November 11 th, 4:30 PM – 4:45 PM
#P099 Inhaler Technique Maintenance In Patients With Uncontrolled Asthma Using A Reliever Digital System (CONNECT1)
Session: TBC
Date/Time: Friday, November 11 th, 4:45 PM – 5:00 PM
#P101 Usability Scores Of A Reliever Digital System In Patients With Uncontrolled Asthma (CONNECT1)
Session: TBC
Date/Time: Friday, November 11 th, 5:00 PM – 5:15 PM
ProAir Digihaler Indications and Usage
ProAir Digihaler (albuterol sulfate) Inhalation Powder is a prescription medicine used in people ≥4 years of age for the treatment or prevention of bronchospasm in people who have reversible obstructive airway disease and for the prevention of exercise-induced bronchospasm.
Important Safety Information About ProAir Digihaler
Please read the full Prescribing Information.
AirDuo Digihaler Indications and Usage
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.
Important Safety Information About AirDuo Digihaler
Please see full Prescribing Information for AirDuo 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, 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. You can identify these forward-looking statements by the use of words such as “should,” “expect,” “anticipate,” “estimate,” “target,” “may,” “project,” “guidance,” “intend,” “plan,” “believe” and other words and terms of similar meaning and expression in connection with any discussion of future operating or financial performance. Important factors that could cause or contribute to such differences include risks relating to the development and commercial success of our digihaler products family, including ProAir Digihaler and AirDuo Digihaler; our ability to successfully compete in the marketplace, including our ability to develop and commercialize biopharmaceutical products, competition for our specialty products, including AUSTEDO ®, AJOVY ® and COPAXONE ®; our ability to achieve expected results from investments in our product pipeline, our ability to develop and commercialize additional pharmaceutical products, and the effectiveness of our patents and other measures to protect our intellectual property rights; our substantial indebtedness; our business and operations in general; costs and delays resulting from the extensive pharmaceutical regulation to which we are subject or delays in governmental processing time due to travel and work restrictions caused by the COVID-19 pandemic; compliance, regulatory and litigation matters, including failure to comply with complex legal and regulatory environments; other financial and economic risks; and other factors discussed in our Quarterly Report on Form 10-Q for the third quarter of 2022 and in our Annual Report on Form 10-K for the year ended December 31, 2021, including in the section 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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CONTACT: IR Contacts
Ran Meir (267) 468-4475
Yael Ashman +972 (3) 914 8262
PR Contacts
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KEYWORD: KENTUCKY NEW JERSEY UNITED STATES NORTH AMERICA ISRAEL MIDDLE EAST
INDUSTRY KEYWORD: HEALTH FDA OTHER HEALTH GENERAL HEALTH CLINICAL TRIALS PHARMACEUTICAL BIOTECHNOLOGY
SOURCE: Teva Pharmaceutical Industries Limited
Copyright Business Wire 2022.
PUB: 11/07/2022 04:30 PM/DISC: 11/07/2022 04:32 PM
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