- The first and only family of digital,
breath-actuated inhalers with built-in sensors that track inhaler
events and measure inspiratory flow
- Digihaler® app provides patients the ability
to view and share objective inhaler use data with their healthcare
providers (HCPs)
- The Digihaler® family of inhalers now
available by prescription in the U.S.
Teva Respiratory, LLC., a U.S. affiliate of Teva Pharmaceutical
Industries Ltd. (NYSE and TASE: TEVA) today announced the launch of
AirDuo® Digihaler® (fluticasone propionate and salmeterol)
inhalation powder and ArmonAir® Digihaler® (fluticasone propionate)
inhalation powder, two digital maintenance inhalers for patients
with asthma. AirDuo® Digihaler® is a prescription medicine used to
control symptoms of asthma and to prevent symptoms such as wheezing
in people 12 years of age and older. ArmonAir® Digihaler® is a
prescription medicine for the long-term treatment of asthma in
patients 12 years and older. AirDuo® Digihaler® and ArmonAir®
Digihaler® are not used to relieve sudden breathing problems from
asthma and will not replace the need for a rescue inhaler.
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“Being able to now offer AirDuo® Digihaler® and ArmonAir®
Digihaler® to patients is an exciting step forward for Teva, and
one that we are extremely proud of,” said Brendan O’Grady,
Executive Vice President, North America Commercial at Teva
Pharmaceuticals. “With the launch of these two maintenance
products, we’re now able to offer the full Digihaler® portfolio to
patients, potentially allowing them to gain an even deeper
understanding of their overall asthma treatment regimen due in part
to the data collection capabilities of the Digihaler® portfolio of
products.”
Both products contain built-in Bluetooth® Wireless Technology,
which connect to a companion mobile app and provide data on inhaler
use, which is recorded as an event when the cap is opened or a
patient inhales. AirDuo® Digihaler® and ArmonAir® Digihaler® are
part of Teva’s Digihaler® portfolio, which also includes ProAir®
Digihaler®, 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). All three
products are now commercially available to patients by
prescription. Please view the Important Safety Information for
these products below.
“The launch of AirDuo® Digihaler® and ArmonAir® Digihaler®
completes our portfolio of digitally connected inhalers and allows
Teva to provide maintenance and rescue digital inhaler options to
the U.S. respiratory community, especially in a time when digital
health tools are more important than ever,” said Sven Dethlefs,
Executive Vice President, Global Marketing & Portfolio at Teva
Pharmaceuticals. “The full Digihaler® family is a major step
forward for digital health technologies in helping to transform
patient care, and we hope it will enable patients and their
healthcare providers to better inform treatment decisions. For
Teva, the Digihaler® launch is the starting point for new
software-based innovations in respiratory, moving treatment options
beyond new therapeutic entities.”
The AirDuo® Digihaler® and ArmonAir® Digihaler® inhalers
automatically detect, record and store objective inhaler use data,
including peak inspiratory flow. Both products have the ability to
remind the patient how often the devices have been used, measure
inspiratory flow rates and determine if inhalation technique may
need improvement. This usage and inspiratory flow data are then
directly sent to the Digihaler® app via Bluetooth® technology,
giving patients the ability to share their data with healthcare
providers (HCPs) if they choose to. Access to this data may allow
HCPs to make more informed treatment decisions.
AirDuo® Digihaler® was approved by the U.S. Food and Drug
Administration (FDA) in July 2019 in a low, medium and high dose:
55/14 mcg, 113/14 mcg and 232/14 mcg administered as one inhalation
twice daily. ArmonAir® Digihaler® was approved by the FDA in
February 2020 in a low, medium and high dose: 55 mcg, 113 mcg and
232 mcg administered as one inhalation twice daily.
“Until now, I have had to rely on my patients’ memory to share
the details of their inhaler use habits with me – which, despite
their best efforts, can be difficult and confusing. Being able to
see my patients’ rescue and maintenance inhaler use data can help
me assess if they are using their inhalers as prescribed,” said Dr.
J. Allen Meadows, MD, FACAAI, Clinical Faculty, Alabama College of
Osteopathic Medicine. “In addition, getting access into their
inspiratory flow rates may also help me identify patients who might
need coaching in inhaler technique improvement.”
The Wholesale Acquisition Cost (WAC or “list price”) for AirDuo®
Digihaler® in the doses 55/14 mcg and 113/14 mcg is $399 and the
WAC price for the 232/14 mcg dose is $449. The WAC price of
ArmonAir® Digihaler® in the doses 55 mcg and 113 mcg is $239 and
the WAC price for the 232 mcg dose is $299. Actual costs to
individual patients and providers for both products 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.
APPROVED USES AND IMPORTANT SAFETY INFORMATION FOR AIRDUO®
DIGIHALER® AND ARMONAIR® DIGIHALER®
APPROVED USES
- AIRDUO® DIGIHALER® (fluticasone propionate and
salmeterol) inhalation powder is a prescription medicine used to
control symptoms of asthma and to prevent symptoms such as wheezing
in people 12 years of age and older.
- ARMONAIR® DIGIHALER® (fluticasone propionate) inhalation
powder is a prescription medicine for the long-term treatment of
asthma in patients 12 years and older.
- AIRDUO DIGIHALER and ARMONAIR DIGIHALER are not
used to relieve sudden breathing problems from asthma and won't
replace a rescue inhaler.
AIRDUO DIGIHALER and ARMONAIR DIGIHALER each
contain a built-in electronic module that records and stores
information about inhaler events. AIRDUO DIGIHALER and
ARMONAIR DIGIHALER may be used with, and transmit
information to, a mobile App.
AIRDUO DIGIHALER and ARMONAIR DIGIHALER do not need to
be connected to the app in order for you to take your
medicine.
IMPORTANT SAFETY INFORMATION
- AIRDUO DIGIHALER contains salmeterol. Long-acting
beta2-agonist (LABA) medicines such as salmeterol when used alone
increase the risk of hospitalizations and death from asthma
problems. AIRDUO DIGIHALER contains an inhaled
corticosteroid (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.
- Do not use AIRDUO DIGIHALER or ARMONAIR
DIGIHALER to treat sudden breathing problems from asthma.
Always have a rescue inhaler with you to treat sudden
symptoms.
- Do not use AIRDUO DIGIHALER or ARMONAIR
DIGIHALER if you have a severe allergy to milk proteins or if
you are allergic to any of the ingredients in the product. Ask your
healthcare provider if you are not sure.
- Do not use AIRDUO DIGIHALER or ARMONAIR
DIGIHALER more often than prescribed.
- Do not take AIRDUO DIGIHALER with other medicines that
contain a LABA for any reason.
- Tell your healthcare provider about all the medicines you
take and about all of your health conditions.
- Do not stop using ARMONAIR DIGIHALER, even if you
are feeling better, unless your healthcare provider tells you to.
If you miss a dose of ARMONAIR DIGIHALER, just skip that
dose. Take your next dose at your usual time. Do not take 2 doses
at 1 time.
- AIRDUO DIGIHALER and ARMONAIR DIGIHALER can cause serious
side effects, including:
- Fungal infection in your mouth or throat (thrush). Rinse
your mouth with water without swallowing after using AIRDUO
DIGIHALER or ARMONAIR DIGIHALER to help reduce your
chance of getting thrush.
- Weakened immune system and increased chance of getting
infections (immunosuppression). You should avoid exposure to
chickenpox and measles, and, if exposed, tell your healthcare
provider right away. Worsening of existing tuberculosis, fungal,
bacterial, viral, or parasitic infections, or herpes infection of
the eye (ocular herpes simplex) may occur.
- Reduced adrenal function. This can happen when you stop
taking an oral corticosteroid (such as prednisone) and start taking
a medicine containing an ICS (such as AIRDUO DIGIHALER or
ARMONAIR DIGIHALER). During this transition period, when
your body is under stress such as from fever, trauma (such as a car
accident), infection, or surgery, adrenal insufficiency can get
worse and may cause death. Symptoms of adrenal insufficiency
include:
- feeling tired
- lack of energy
- Weakness
- nausea and vomiting
- low blood pressure
- For AIRDUO DIGIHALER, there may be sudden breathing
problems immediately after inhaling your medicine. If you have
sudden breathing problems immediately after inhaling your medicine,
stop using AIRDUO DIGIHALER and call your healthcare
provider right away.
- Serious allergic reactions. Stop using AIRDUO
DIGIHALER or ARMONAIR DIGIHALER and call your healthcare
provider or get emergency medical care if you get any of the
following symptoms of a serious allergic reaction:
- rash
- hives
- swelling of your face, mouth, and tongue
- breathing problems
- AIRDUO DIGIHALER can also cause additional serious side
effects, including:
- Effects on the heart
- increased blood pressure
- a fast or irregular heartbeat
- chest pain
- Effects on the nervous system
- AIRDUO DIGIHALER and ARMONAIR DIGIHALER can
cause:
- Bone thinning or weakness (osteoporosis)
- Slowed growth in children. A child's growth should be
checked often.
- Eye problems including glaucoma and cataracts. You
should have regular eye exams while using AIRDUO DIGIHALER
or ARMONAIR DIGIHALER.
- For AIRDUO DIGIHALER, changes may occur in laboratory blood
values (sugar, potassium, certain types of white blood
cells)
- For ARMONAIR DIGIHALER increased wheezing (bronchospasm) may
occur. Increased wheezing can happen right away after using
ARMONAIR DIGIHALER. If this occurs, stop using ARMONAIR
DIGIHALER and call your healthcare provider. Always have a
rescue inhaler with you to treat sudden wheezing.
- Common side effects of AIRDUO DIGIHALER and ARMONAIR
DIGIHALER include:
- thrush in your mouth or throat. Rinse your mouth with water
without swallowing after use to help prevent this.
- Headache
- cough
- Additionally, AIRDUO DIGIHALER has common side effects
of:
- back pain
- infection of nose and throat (nasopharyngitis)
- ARMONAIR DIGIHALER has common side effects of:
- upper respiratory tract infection
- infection or inflammation of nose and throat
(nasopharyngitis)
- These are not all the possible side effects of AIRDUO
DIGIHALER and ARMONAIR DIGIHALER. Call your healthcare
provider for medical advice about side effects.
- 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 see full Prescribing Information for AIRDUO
DIGIHALER and ARMONAIR DIGIHALER.
APPROVED USES FOR PROAIR® DIGIHALER®
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 patients to take their medicine.
IMPORTANT SAFETY INFORMATION FOR PROAIR® DIGIHALER®
- 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 for ProAir
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
regarding AirDuo® Digihaler® and ArmonAir® 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 commercial success of our Digihaler family of
inhalers;
- our ability to successfully compete in the marketplace,
including: that we are substantially dependent on our generic
products; 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;
competition for our specialty products, especially COPAXONE®, our
leading medicine, which faces competition from existing and
potential additional generic versions, competing glatiramer acetate
products and orally-administered alternatives; the uncertainty of
commercial success of AJOVY® or AUSTEDO®; competition from
companies with greater resources and capabilities; delays in
launches of new products and our ability to achieve expected
results from investments in our product pipeline; ability to
develop and commercialize biopharmaceutical products; efforts of
pharmaceutical companies to limit the use of generics, including
through legislation and regulations and the effectiveness of our
patents and other measures to protect our intellectual property
rights;
- our substantial indebtedness, 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: uncertainty
regarding the magnitude, duration, and geographic reach of the
COVID-19 pandemic and its impact on our business, financial
condition, operations, cash flows, and liquidity and on the economy
in general; our ability to successfully execute and maintain the
activities and efforts related to the measures we have taken or may
take in response to the COVID-19 pandemic and associated costs
therewith; effectiveness of our restructuring plan announced in
December 2017; our ability to attract, hire and retain highly
skilled personnel; our ability to develop and commercialize
additional pharmaceutical products; compliance with anti-corruption
sanctions and trade control laws; manufacturing or quality control
problems; interruptions in our supply chain, including due to
potential effects of the COVID-19 pandemic on our operations and
business in geographic locations impacted by the pandemic and on
the business operations of our suppliers; disruptions of
information technology systems; breaches of our data security;
variations in intellectual property laws; challenges associated
with conducting business globally, including adverse effects of the
COVID-19 pandemic, political or economic instability, major
hostilities or terrorism; significant sales to a limited number of
customers; our ability to successfully bid for suitable acquisition
targets or licensing opportunities, or to consummate and integrate
acquisitions; our prospects and opportunities for growth if we sell
assets; and potential difficulties related to the operation of our
new global enterprise resource planning (ERP) system;
- compliance, regulatory and litigation matters, including: our
ability to successfully defend against the DOJ criminal charges of
a Sherman Act violations; increased legal and regulatory action in
connection with public concern over the abuse of opioid medications
in the U.S. and our ability to reach a final resolution of the
remaining opioid-related litigation; costs and delays resulting
from the extensive governmental regulation to which we are subject
or delays in governmental processing time due to modified
government operations due to the COVID-19 pandemic, including
effects on product and patent approvals due to the COVID-19
pandemic; the effects of reforms in healthcare regulation and
reductions in pharmaceutical pricing, reimbursement and coverage;
governmental investigations into S&M 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 Quarterly Reports on Form
10-Q for the first and second quarters of 2020 and in 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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IR Contacts: Kevin C. Mannix United States (215) 591-8912
Ran Meir Israel 972 (3) 926-7516
PR Contacts: Yonatan Beker Israel 972 (54) 888-5898
Doris Li United States (973) 295-7563
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