Bluetooth® Wireless Technology, Flow 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.
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“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
innovations.”
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., Senior Vice President, Global Specialty Clinical
Development 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.
APPROVED USES
ProAir® Digihaler™ (albuterol sulfate) Inhalation Powder is a
prescription medicine used in people 4 years of age and older
to:
- treat or prevent bronchospasm in people
who have reversible obstructive airway disease
- prevent exercise-induced
bronchospasm
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.
IMPORTANT SAFETY INFORMATION
- Do not use ProAir Digihaler
(albuterol sulfate) Inhalation Powder if you are allergic to
albuterol sulfate, lactose, milk proteins, or any of the
ingredients in ProAir Digihaler. Ask your healthcare provider if
you have any questions or are not sure
- Before using ProAir Digihaler, tell
your healthcare provider about all of your medical conditions,
including if you:
- have heart problems
- have high blood pressure
(hypertension)
- have convulsions (seizures)
- have thyroid problems
- have diabetes
- have low potassium levels in your
blood
- are pregnant or planning to become
pregnant
- are breastfeeding or planning to
breastfeed
- Tell your healthcare provider about
all the medicines you take, especially:
- other inhaled medicines or asthma
medicines
- beta blocker medicines
- diuretics
- digoxin
- monoamine oxidase inhibitors
- tricyclic antidepressants
- Do not increase your dose or
take extra doses of ProAir Digihaler without first talking to your
healthcare provider
- Get medical help right away if ProAir
Digihaler no longer helps your symptoms, your symptoms get worse or
you need to use your inhaler more often
- While you are using ProAir Digihaler,
do not use other inhaled rescue medicines and asthma
medicines unless your healthcare provider tells you to do so
- ProAir Digihaler may cause serious
side effects, including:
- worsening trouble breathing,
coughing and wheezing (paradoxical bronchospasm). If this
happens, stop using ProAir Digihaler and call your healthcare
provider or get emergency help right away. This is more likely to
happen with your first use of a new asthma inhalation medicine
- heart problems, including faster
heart rate and higher blood pressure
- possible death in people with asthma
who use too much ProAir Digihaler
- allergic reactions. Call your
healthcare provider right away if you have the following symptoms
of an allergic reaction:
- itchy skin
- swelling beneath your skin or in your
throat
- rash
- worsening trouble breathing
- changes in laboratory blood
values (sugar, potassium)
- The most common side effects of ProAir
Digihaler include:
- back pain
- body aches and pain
- upset stomach
- sinus headache
- urinary tract infection
- your heart feels like it is pounding or
racing (palpitations)
- chest pain
- fast heart rate
- shakiness
- nervousness
- headache
- dizziness
- sore throat
- runny nose
- These are not all of the possible side
effects of ProAir Digihaler. For more information, ask your
healthcare provider or pharmacist
- You are encouraged to report negative
side effects of prescription drugs to the FDA.
Visit www.fda.gov/medwatch, or call 1-800-FDA-1088
Please read the full Prescribing Information.
About Teva
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
regarding ProAir® 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:
- the uncertainty of commercial success
of ProAir® Digihaler™.
- our ability to successfully compete in
the marketplace, including: that we are substantially dependent on
our generic products; competition for our specialty products,
especially COPAXONE®, our leading medicine, which faces competition
from existing and potential additional generic versions and
orally-administered alternatives; competition from companies with
greater resources and capabilities; efforts of pharmaceutical
companies to limit the use of generics including through
legislation and regulations; consolidation of our customer base and
commercial alliances among our customers; the increase in the
number of competitors targeting generic opportunities and seeking
U.S. market exclusivity for generic versions of significant
products; price erosion relating to our products, both from
competing products and increased regulation; delays in launches of
new products and our ability to achieve expected results from
investments in our product pipeline; our ability to take advantage
of high-value opportunities; the difficulty and expense of
obtaining licenses to proprietary technologies; and the
effectiveness of our patents and other measures to protect our
intellectual property rights;
- our substantially increased
indebtedness and significantly decreased cash on hand, which may
limit our ability to incur additional indebtedness, engage in
additional transactions or make new investments, may result in a
further downgrade of our credit ratings; and our inability to raise
debt or borrow funds in amounts or on terms that are favorable to
us;
- our business and operations in general,
including: failure to effectively execute our restructuring plan
announced in December 2017; uncertainties related to, and failure
to achieve, the potential benefits and success of our new senior
management team and organizational structure; harm to our pipeline
of future products due to the ongoing review of our R&D
programs; our ability to develop and commercialize additional
pharmaceutical products; potential additional adverse consequences
following our resolution with the U.S. government of our FCPA
investigation; compliance with sanctions and other trade control
laws; manufacturing or quality control problems, which may damage
our reputation for quality production and require costly
remediation; interruptions in our supply chain; disruptions of our
or third party information technology systems or breaches of our
data security; the failure to recruit or retain key personnel;
variations in intellectual property laws that may adversely affect
our ability to manufacture our products; challenges associated with
conducting business globally, including adverse effects of
political or economic instability, major hostilities or terrorism;
significant sales to a limited number of customers in our U.S.
market; our ability to successfully bid for suitable acquisition
targets or licensing opportunities, or to consummate and integrate
acquisitions; and our prospects and opportunities for growth if we
sell assets;
- compliance, regulatory and litigation
matters, including: costs and delays resulting from the extensive
governmental regulation to which we are subject; the effects of
reforms in healthcare regulation and reductions in pharmaceutical
pricing, reimbursement and coverage; governmental investigations
into sales and marketing practices; potential liability for patent
infringement; product liability claims; increased government
scrutiny of our patent settlement agreements; failure to comply
with complex Medicare and Medicaid reporting and
payment obligations; and environmental risks;
- other financial and economic risks,
including: our exposure to currency fluctuations and restrictions
as well as credit risks; potential impairments of our intangible
assets; potential significant increases in tax liabilities; and the
effect on our overall effective tax rate of the termination or
expiration of governmental programs or tax benefits, or of a change
in our business; and other factors discussed in our Annual Report
on Form 10-K for the year ended December 31, 2017, including in the
section captioned “Risk Factors,” and in our other filings with the
U.S. Securities and Exchange Commission, which are available at
www.sec.gov and www.tevapharm.com. 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.
1.
National Center for Health Statistics.
Centers for Disease Control. Asthma. 2014.
http://www.cdc.gov/nchs/fastats/asthma.htm.
2. Fink JB, Rubin BK. Problems with inhaler use: a call for
improved clinician and patient education. Respir Care.
2005;50(10):1360-1374. 3.
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
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IR Contacts:
Kevin C. MannixUnited States(215) 591-8912
Ran MeirUnited States972 (3) 926-7516
PR Contacts:
Yonatan BekerIsrael972 (54) 888-5898
Doris SaltkillUnited States(913) 777-3343
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