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Sensors and Companion Mobile Application Track Inhaler Use in
People with Asthma & COPD
Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) announced
today that the U.S. Food and Drug Administration (FDA) has approved
ProAir® Digihaler™ (albuterol sulfate 117 mcg) inhalation
powder, the first and only digital inhaler with built-in sensors which
connects to a companion mobile application and provides inhaler use
information to people with asthma and COPD. ProAir®
Digihaler™ is 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 aged four years and older.
“This approval marks a significant milestone not only for Teva, but for
the respiratory community as it allows patients and their caregivers to
better understand inhaler usage through digital technology,” said Sven
Dethlefs, Executive Vice President, Global Marketing & Portfolio. “Teva
recognizes the importance of integrating technology into patient care,
and we are very proud to lead the way with the approval of ProAir®
Digihaler™. The digital technology built into ProAir®
Digihaler™ provides patients with data on their inhaler use, which may
help them to have a more informed dialogue with their healthcare
provider regarding their asthma or COPD management.”
ProAir® Digihaler™ contains built-in sensors that detect when
the inhaler is used and measure inspiratory flow. This inhaler-use data
is then sent to the companion mobile app using Bluetooth® Wireless
Technology so patients can review their data over time, and if desired,
share it with their healthcare professionals.
“There are 25 million Americans living with asthma1, many of
whom use inhalers as part of their treatment regimen. Despite
advancements in care over the years, we know that many are using their
rescue medications incorrectly2 or too often3,”
said Tonya Winders, President & CEO of the Allergy & Asthma Network.
“The FDA approval of ProAir® Digihaler™ is
significant because it may help patients track their inhaler usage and
provide data that can be used to work more closely with their HCPs on
their asthma management. This approval is a major step forward and is
indicative of how medications are evolving through technological
The approval of ProAir® Digihaler™ is based on the review of
a supplemental new drug application (sNDA) submitted by Teva to the FDA.
ProAir® Digihaler™ combines a breath-activated, multi-dose
dry powder inhaler with albuterol, the most widely used asthma rescue
medication, with a built-in electronic module and a companion mobile app.
“One of the challenges physicians are faced with in caring for their
asthma and COPD patients is knowing if their patients are using their
inhaled medication as they should. That’s what makes a product like this
so important to doctor-patient discussions,” said Tushar Shah, M.D.,
Global Head of Specialty Clinical Development & Medical Affairs at Teva
Pharmaceuticals. “Offering a tool that enables doctors to see data on
their patients’ inhaler usage will allow them to have more productive
conversations about identifying issues and how to manage their illness.”
ProAir® Digihaler™ will be available in 2019 through a small
number of “Early Experience” Programs, which will be conducted in
partnership with healthcare systems and in limited geographies, in order
to gather real-world experience. A national launch is planned for 2020.
For more information, visit www.ProAirDigihaler.com.
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
IMPORTANT SAFETY INFORMATION
Please read the full Prescribing
Teva Pharmaceutical Industries Ltd. is a global leader in generic
medicines, with innovative treatments in select areas, including CNS,
pain and respiratory. We deliver high-quality generic products and
medicines in nearly every therapeutic area to address unmet patient
needs. We have an established presence in generics, specialty, OTC and
API, building on more than a century-old legacy, with a fully integrated
R&D function, strong operational base and global infrastructure and
scale. We strive to act in a socially and environmentally responsible
way. Headquartered in Israel, with production and research facilities
around the globe, we employ 45,000 professionals, committed to improving
the lives of millions of patients. Learn more at www.tevapharm.com.
Teva 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
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:
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.
National Center for Health Statistics. Centers for Disease
Control. Asthma. 2014. http://www.cdc.gov/nchs/fastats/asthma.htm.
The Journal of Allergy and Clinical Immunology: In Practice.
Quantifying beta-agonist utilization: Occasions or puffs?,
September 13, 2018. Accessed on October 10, 2018. Available at: https://www.sciencedirect.com/science/article/pii/S2213219818305774?via%3Dihub
View source version on businesswire.com:
Kevin C. Mannix
United States(215) 591-8912
United States972 (3) 926-7516
Israel972 (54) 888-5898
United States(913) 777-3343
Source: Teva Pharmaceutical Industries Ltd.