- First and Only Digital Rescue Inhaler with
Built-In Sensors Now Available By Prescription to Patients in the
U.S.
- Companion App Provides Objective Inhaler
Event Data, Including Peak Inspiratory Flow. This data may be used
to facilitate Health Care Provider-Patient Communication
- Complete Digihaler® Portfolio Expected to be
Available in the U.S. By Prescription Later This Year
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:
- 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.
PROAIR® DIGIHALER® 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 for ProAir
Digihaler.
AIRDUO® DIGIHALER® APPROVED USES
- 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.
- AirDuo Digihaler is not used to relieve sudden breathing
problems from asthma and won't replace a rescue inhaler. 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.
AIRDUO® DIGIHALER® 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 to treat sudden breathing
problems from asthma. Always have a rescue inhaler with you to
treat sudden symptoms.
- Do not use AirDuo 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 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.
- AirDuo 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 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 inhaled corticosteroid (such as AirDuo
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
- 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
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
- Effects on heart
- increased blood pressure
- a fast or irregular heartbeat
- chest pain
- Effects on nervous system
- 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.
- Changes in laboratory blood values (sugar, potassium,
certain types of white blood cells)
- Common side effects of AirDuo Digihaler include:
- Infection of nose and throat (nasopharyngitis)
- thrush in your mouth or throat. Rinse your mouth with water
without swallowing after use to help prevent this.
- back pain
- headache
- cough
- These are not all the possible side effects of AirDuo
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.
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® DIGIHALER™ IMPORTANT SAFETY INFORMATION
- Do not use ArmonAir Digihaler to treat sudden breathing
problems from asthma. Always have a rescue inhaler with you to
treat sudden symptoms.
- Do not use 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.
- Tell your healthcare provider about all the medicines you
take and about all of your health conditions.
- Do not use ArmonAir Digihaler more often than
prescribed.
- 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.
- 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 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 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
- serious allergic reactions. Stop using 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
- 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 ArmonAir Digihaler.
- increased wheezing (bronchospasm). 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 ArmonAir Digihaler include:
- infection or inflammation of nose and throat
(nasopharyngitis)
- upper respiratory tract infection
- thrush in your mouth or throat. Rinse your mouth with water
without swallowing after use to help prevent this.
- headache
- cough
- These are not all the possible side effects of 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 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:
- the commercial success of Teva’s Digihaler® portfolio;
- 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: 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; 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
customers and suppliers; adequacy of and 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;
implementation of our restructuring plan announced in December
2017; challenges associated with conducting business globally,
including adverse effects of the COVID-19 pandemic, political or
economic instability, major hostilities or terrorism; 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; disruptions of
information technology systems; breaches of our data security;
variations in intellectual property laws; 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:
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 including due to modified government
operations due to the COVID-19 pandemic and effects on product and
patent approvals; 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 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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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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