Teva’s Digital Inhaler Portfolio Now Includes
Products from Three of the Most Commonly Prescribed Classes of
Asthma Treatments
Teva Respiratory, LLC, an affiliate of Teva Pharmaceutical
Industries Ltd. (NYSE and TASE: TEVA) announced today that the U.S.
Food and Drug Administration (FDA) has approved ArmonAir®
Digihaler™ (fluticasone propionate) Inhalation Powder, an inhaled
corticosteroid (ICS) delivered via Teva’s Digihaler™ device, which
contains built-in sensors and connects to a companion mobile
application that provides information on inhaler use to people with
asthma. ArmonAir® Digihaler™ is indicated for the maintenance
treatment of asthma in patients 12 years and older. ArmonAir®
Digihaler™ is not indicated for the relief of acute
bronchospasm.
ArmonAir® Digihaler™ joins the approved Digihaler™ portfolio of
products, including ProAir® Digihaler™ (albuterol sulfate 117 mcg)
Inhalation Powder, which is indicated for use in patients 4 years
of age and older to treat or prevent bronchospasm in those who have
reversible obstructive airway disease and to prevent
exercise-induced bronchospasm, and AirDuo® Digihaler™ (fluticasone
propionate and salmeterol) Inhalation Powder, which is indicated
for the maintenance treatment of asthma in patients 12 years of age
and older. The Digihaler™ device detects when the inhaler is used
and measures inspiratory flow rates. These data are then sent to a
companion mobile app using Bluetooth® Wireless Technology so that
patients can review their data over time, and if desired, share it
with their healthcare providers to have more informed discussions
about their condition and treatment. Patients also can schedule
reminders on their smartphone to take either their ArmonAir®
Digihaler™ or AirDuo® Digihaler™ as prescribed. Please view the
Important Safety Information for these products below.
“My patients often struggle to remember to take their medicine
and track their maintenance and rescue medication usage which can
play a significant role in asthma management,” said Dr. Nabeel
Farooqui, MD, FAAAAI, FACAAI, Assistant Professor, Department of
Medicine, Indiana University School of Medicine. “Enabling patients
to track their inhaler use data, including frequency and
inspiratory flow rates, each time they use their inhaler, can play
a significant role in helping me have open, informed conversations
with them about how best to manage their condition.”
“The approval of a third product in the Digihaler™ portfolio is
an incredibly exciting milestone for us,” said Sven Dethlefs,
Executive Vice President, Global Marketing & Portfolio. “Our
portfolio now includes a rescue treatment, a maintenance
combination therapy, and now a maintenance monotherapy. All three
of these digital inhalers with built-in sensors pair with companion
mobile apps, allowing patients to track their inhaler use across
multiple digital devices and have a better understanding of their
condition. Patients may also choose to share this data with their
healthcare providers.”
The approval of ArmonAir® Digihaler™ is based on the review of
the supplemental new drug application (sNDA) submitted by Teva to
the FDA. ArmonAir® Digihaler™ was approved in a low, medium and
high dose: 55 mcg, 113 mcg and 232 mcg administered as one
inhalation twice daily.
“Twenty-five million Americans are living with asthma1, and it’s
important that they track their medication use and frequency to
ensure they are managing the disease appropriately,” said Tonya
Winders, President & CEO of the Allergy & Asthma Network.
“Thanks to technological advancements like these, the ability to
monitor this type of data for different types of asthma medications
can help patients foster open conversations with their healthcare
providers, in an effort to ensure their asthma is
well-managed.”
The complete Digihaler™ portfolio is expected to become
commercially available to patients later this year.
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.
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.
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 you to take your 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.
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 FDA approval of 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 ArmonAir Digihaler;
- 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 oyrally-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:
implementation 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; 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 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:
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; 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 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.
______________________________________
- National Center for Health Statistics. Centers for Disease
Control. Asthma. 2017.
http://www.cdc.gov/nchs/fastats/asthma.htm.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20200224005511/en/
IR Contacts United States Kevin C. Mannix (215) 591-8912
Israel Ran Meir 972 (3) 926-7516 PR Contacts
United States Doris Li 973-295-7563 Israel Yonatan
Beker 972 (54) 888 5898
Teva Pharmaceutical Indu... (NYSE:TEVA)
Historical Stock Chart
From Mar 2024 to Apr 2024
Teva Pharmaceutical Indu... (NYSE:TEVA)
Historical Stock Chart
From Apr 2023 to Apr 2024