The First Digital Maintenance Asthma Inhaler
Therapy with Integrated Sensors Joins Teva’s Digital Rescue Inhaler
Therapy to Provide Patients with Technology to Track Treatment
Use
Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA)
announced today that the U.S. Food and Drug Administration (FDA)
has approved AirDuo® Digihaler™ (fluticasone propionate 113 mcg and
salmeterol 14 mcg) Inhalation Powder, a combination therapy digital
inhaler with built-in sensors that connects to a companion mobile
application to provide information on inhaler use to people with
asthma. AirDuo® Digihaler™ is indicated for the treatment of asthma
in patients aged 12 years and older. AirDuo® Digihaler™ is not used
to relieve sudden breathing problems and won’t replace a rescue
inhaler.
“We are thrilled to be able to expand our Digihaler™ portfolio
to now include a maintenance treatment,” said Tushar Shah, M.D.,
Global Head of Specialty Clinical Development at Teva
Pharmaceuticals. “With this approval, patients can now track how
frequently they are using their inhalers. Granting patients the
ability to track their maintenance inhaler use may help inform
conversations with their doctors about treatment adherence and
proper technique.”
Like ProAir® Digihaler™ (albuterol sulfate 117 mcg) inhalation
powder, 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 four years and older, AirDuo® Digihaler™ contains
built-in sensors that detect when the inhaler is used and measure
inspiratory flow rates. This data is 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. Patients can also schedule reminders on
their smartphone to take their AirDuo® Digihaler™ as
prescribed.
“Even the most diligent asthma patients may not realize they are
not following their treatment regimen, despite their best efforts,”
said Dr. Nabeel Farooqui, MD, FAAAAI, FACAAI, Assistant Professor,
Department of Medicine, Indiana University School of Medicine. “The
ability to now measure their inspiratory flow rates and track their
maintenance medication use, as well as the frequency with which
they use their inhaler, may provide important data and insights to
help inform treatment discussions with physicians. As a doctor,
it’s exciting that my patients are able to share this type of
information with me.”
The approval of AirDuo® Digihaler™ is based on the review of the
supplemental new drug application (sNDA) submitted by Teva to the
FDA. AirDuo® Digihaler™ combines a breath-actuated, multi-dose dry
powder inhaler with fluticasone propionate, an inhaled
corticosteroid (ICS) medicine that may help to decrease
inflammation in the lungs, which can lead to breathing problems,
and salmeterol, a long acting beta2 adrenergic agonist (LABA),
which helps the muscles around the airways in the lungs stay
relaxed in order to prevent symptoms. AirDuo® Digihaler™ contains
salmeterol. LABA medicines such as salmeterol when used alone
increase the risk of hospitalizations and death from asthma
problems. AirDuo® Digihaler™ contains an 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.
AirDuo® Digihaler™ was approved in a low, medium and high dose:
55/14 mcg, 113/14 mcg and 232/14 mcg administered as one inhalation
twice daily. As a fixed dose combination asthma therapy containing
an ICS and a LABA, AirDuo® Digihaler™ contains the same active
ingredients as Advair Diskus®, which is also approved in low,
medium and high doses: 100/50 mcg, 250/50 mcg and 500/50 mcg.
“For the 25 million Americans living with asthma1, advancements
like this one are important and could help patients track their
inhaler use and frequency,” said Tonya Winders, President & CEO
of the Allergy & Asthma Network. “Allowing patients access to
both their rescue and maintenance inhaler use information on their
smartphones is a promising step towards potentially fostering
greater discussions about asthma management.”
“The approval of AirDuo® Digihaler™ is an important step for
Teva and the respiratory community to create a technology platform
for use in asthma management along with the previously-approved
ProAir® Digihaler™,” said Sven Dethlefs, Executive Vice President,
Global Marketing & Portfolio. “This technology aims at
delivering innovations through cloud-based services with the target
to provide new insights to guide treatment choices for caregivers
to help them improve outcomes for asthma patients.”
AirDuo® Digihaler™ is expected to become commercially available
to patients by prescription in 2020. For more information, visit
www.AirDuoDigihaler.com.
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
different 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, 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 AirDuo®
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; the uncertainty of commercial
success of AJOVY® and AUSTEDO®; 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 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: 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 selling 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, 2018, including the sections
thereof captioned "Risk Factors." 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.
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