- Real-world insights fueled by Digihaler technology and utility
of its data in patients with asthma
- Digihaler is the first and only smart inhaler system that can
provide objective data to help patients and their doctors better
support asthma management
Teva Pharmaceuticals USA, Inc., a U.S. affiliate of Teva
Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA), today
announced that new data on its Digihaler System will be presented
at the American Academy of Allergy, Asthma and Immunology (AAAAI)
2023 Annual Meeting, being held February 24-27 in San Antonio,
Texas. The data includes findings from the CONNECT2 clinical trial
program as well as information on patients and healthcare
professionals' real-world use of the smart inhaler system. The
Digihaler System is the first and only smart inhaler system with
built-in sensors that provide objective inhaler event data to help
patients and their doctors support asthma management and develop
personalized treatment plans.
The data will be featured in five posters, which will
highlight:
- Real-world Digihaler System usage patterns for patients
- The relationship between medication adherence and patients’
voluntary responses to a daily self-assessment (DSA) feature
- Barriers, facilitators, and HCP recommendations related to
implementation of digital inhaler technology
“The data we are presenting at AAAAI share meaningful insights
for doctors and asthma patients about asthma management based on
information provided by the Digihaler System,” said Tanisha Hill,
Senior Medical Director, Respiratory and Digital Health Medical
Lead at Teva. “Understanding trends around adherence and predictors
of success in disease management are important to informing more
personalized treatment.”
Digihaler is a digital health system comprised of an electronic
multi-dose dry powder smart inhaler, connected app, Digital Health
Platform cloud solution and dashboard. Digihaler inhalers have
built-in flow sensors that detect, record and store objective data
showing how often and how well patients use their inhalers, as
measured by inspiratory flow. Patients are able to view their data
on the Digihaler app, including inhaler use patterns over time, and
can share it with a healthcare provider to facilitate dialogue and
personalize treatment discussions. Healthcare providers can also
monitor the data on a dashboard with patient permission.
As per the U.S. Food and Drug Administration (FDA) approved
label, there is no evidence that the use of the app leads to
improved clinical outcomes, including safety and efficacy.
CONNECT2
The CONNECT clinical program evaluated the potential impact of
Digihaler System on patient-provider interactions, adherence over
time, inhaler technique and frequency of short-acting beta agonist
(SABA) use. The CONNECT2 trial was conducted to assess the role of
both the ProAir® Digihaler (albuterol sulfate) inhalation powder
and AirDuo® Digihaler (fluticasone propionate and salmeterol)
inhalation powder in the treatment of asthma as part of the
Digihaler System.
CONNECT2 was a 24-week open-label, multicenter, randomized,
parallel group study that evaluated the impact of this Digihaler
System on asthma management compared to standard of care (SoC) in
427 patients with asthma. Participants in the SoC group continued
treatment with their current SoC asthma maintenance and reliever
medications.
Digihaler integrated inhalers transmit data wirelessly to a
smartphone application (App), which allows for inhaler event
tracking. The App includes a voluntary, non-respiratory-specific
DSA. The DSA includes questions asking how a patient is feeling on
a three-point scale ranging from sad to neutral to happy.
The two CONNECT2 analyses that will be presented at AAAAI
explore:
- The relationship between SABA use and patient self-assessment
responses
- The relationship between medication adherence and patient
self-assessment responses
Real-World Digital Health Platform Analysis
The Digihaler Digital Health Platform allows patients to track
their inhaler events, and inhaler use, which is recorded as an
event when the cap is opened or a patient inhales. The objective
data is collected in the App and can be shared with physicians to
help them make more informed treatment decisions.
The poster that will be presented at AAAAI explores:
- Real-world usage patterns and data from a digital health
platform
Implementation Study
The study was comprised of telephone interviews and web surveys
with specialists who prescribed the digital inhaler to at least one
of their patients with asthma or chronic obstructive pulmonary
disease (COPD). The surveys and semi-structured interviews were
used to evaluate barriers and facilitators to implementation from
participants. Investigators utilized the consolidated framework for
implementation research (CFIR) theoretical framework to better
understand how the Digihaler System was used in clinical practice
and report recommendations from early adopters of the
technology.
The two implementation research posters that will be presented
at AAAAI explore:
- Theory-based implementation research to evaluate barriers and
facilitators to the implementation of digital inhaler technology in
clinical practice
- The real-world implementation of digital inhaler technology in
clinical practice
These poster presentations can be accessed by registering for
the meeting.
Teva-sponsored data to be presented includes:
#P37 Real-World Inhaler Usage Patterns Obtained from a
Digital Health Platform Session: Poster Presentations and Case
Study Posters Date/Time: Friday, February 24th, 3:15 PM – 4:15
PM
#P487 Relationship Between SABA Use and Self-Assessment
Responses in Patients with Asthma Session: Poster Presentations
and Case Study Posters Date/Time: Sunday, February 26th, 9:45 AM –
10:45 AM
#P488 Relationship Between Medication Adherence and
Self-Assessment Responses in Patients with Asthma Session:
Poster Presentations and Case Study Posters Date/Time: Sunday,
February 26th, 9:45 AM – 10:45 AM
#P504 Use of Theory-Based Implementation Research to Evaluate
Barriers and Facilitators to Implementation of a Novel Digital
Inhaler Technology in Clinical Practice Session: Poster
Presentations and Case Study Posters Date/Time: Sunday, February
26th, 9:45 AM – 10:45 AM
#P511 Implementation of a Novel Digital Inhaler Technology in
Real-World Clinical Practice: Experiences and Recommendations from
Early Adopters Session: Poster Presentations and Case Study
Posters Date/Time: Sunday, February 26th, 9:45 AM – 10:45 AM
ProAir Digihaler Indications and Usage
ProAir Digihaler (albuterol sulfate) Inhalation Powder is a
prescription medicine used in people ≥4 years of age for the
treatment or prevention of bronchospasm in people who have
reversible obstructive airway disease and for the prevention of
exercise-induced bronchospasm.
Important Safety Information About ProAir Digihaler
- Contraindications: ProAir Digihaler (albuterol sulfate)
Inhalation Powder is contraindicated in patients with
hypersensitivity to albuterol or patients with a severe
hypersensitivity to milk proteins. Rare cases of hypersensitivity
reactions, including urticaria, angioedema, and rash have been
reported after the use of albuterol sulfate. There have been
reports of anaphylactic reactions in patients using inhalation
therapies containing lactose
- Paradoxical Bronchospasm: ProAir Digihaler can produce
paradoxical bronchospasm that may be life-threatening. Discontinue
ProAir Digihaler and institute alternative therapy if paradoxical
bronchospasm occurs
- Deterioration of Asthma: Need for more doses of ProAir
Digihaler than usual may be a marker of acute or chronic
deterioration of asthma and requires reevaluation of treatment,
such as possible need for anti-inflammatory treatment, e.g.,
corticosteroids
- Use of Anti-Inflammatory Agents: ProAir Digihaler alone
may not be adequate to control asthma in many patients. Early
consideration should be given to adding anti-inflammatory agents,
e.g., corticosteroids
- Cardiovascular Effects: ProAir Digihaler, like other
beta-adrenergic agonists, can produce clinically significant
cardiovascular effects in some patients, as measured by heart rate,
blood pressure, and/or symptoms. If such effects occur, the drug
may need to be discontinued. ProAir Digihaler, like all
sympathomimetic amines, should be used with caution in patients
with cardiovascular disorders, especially coronary insufficiency,
cardiac arrhythmias, and hypertension
- Do Not Exceed Recommended Dose: Fatalities have been
reported in association with excessive use of inhaled
sympathomimetic drugs in patients with asthma
- Hypersensitivity Reactions including Anaphylaxis:
Immediate hypersensitivity reactions may occur after administration
of albuterol sulfate, as demonstrated by rare cases of urticaria,
angioedema, rash, bronchospasm, anaphylaxis, and oropharyngeal
edema. Hypersensitivity reactions including anaphylaxis,
angioedema, pruritus, and rash have been reported with the use of
therapies containing lactose, an inactive ingredient in ProAir
Digihaler
- Coexisting Conditions: ProAir Digihaler, like all
sympathomimetic amines, should be used with caution in patients
with convulsive disorders, hyperthyroidism, or diabetes mellitus;
and in patients who are unusually responsive to sympathomimetic
amines
- Hypokalemia: As with other beta-agonists, ProAir
Digihaler may produce significant hypokalemia in some patients. The
decrease is usually transient, not requiring supplementation
- Most common adverse reactions (≥1% and >placebo) are
back pain, pain, gastroenteritis viral, sinus headache, urinary
tract infection, nasopharyngitis, oropharyngeal pain and
vomiting
- Drug Interactions: Other short-acting sympathomimetic
bronchodilators should not be used concomitantly with ProAir
Digihaler
- Beta-Blockers: Beta-adrenergic-receptor blocking agents
not only block the pulmonary effect of beta-agonists, such as
ProAir Digihaler, but may produce severe bronchospasm in asthmatic
patients. Therefore, patients with asthma should not normally be
treated with beta-blockers
- Diuretics: Caution is advised in the coadministration of
beta-agonists with non-potassium sparing diuretics (such as loop or
thiazide diuretics). Consider monitoring potassium levels
- Digoxin: Carefully evaluate the serum digoxin levels in
patients who are currently receiving digoxin and ProAir
Digihaler
- Monoamine Oxidase Inhibitors or Tricyclic
Antidepressants: ProAir Digihaler should be administered with
extreme caution to patients being treated with these agents, or
within 2 weeks of discontinuation of these agents, because the
action of albuterol on the cardiovascular system may be
potentiated. Consider alternative therapy
Please read the full Prescribing Information.
AirDuo Digihaler Indications and Usage
- 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.
Important Safety Information About AirDuo Digihaler
- 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.
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
innovative 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 innovative 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, 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. You
can identify these forward-looking statements by the use of words
such as “should,” “expect,” “anticipate,” “estimate,” “target,”
“may,” “project,” “guidance,” “intend,” “plan,” “believe” and other
words and terms of similar meaning and expression in connection
with any discussion of future operating or financial performance.
Important factors that could cause or contribute to such
differences include risks relating to the development and
commercial success of our digihaler products family, including
ProAir Digihaler and AirDuo Digihaler; our ability to successfully
compete in the marketplace, including our ability to develop and
commercialize biopharmaceutical products, competition for our
innovative medicines, including AUSTEDO®, AJOVY® and COPAXONE®, our
ability to achieve expected results from investments in our product
pipeline, our ability to develop and commercialize additional
pharmaceutical products, and the effectiveness of our patents and
other measures to protect our intellectual property rights; our
substantial indebtedness; our business and operations in general,
including, the impact of global economic conditions and other
macroeconomic developments and the governmental and societal
responses thereto, and costs and delays resulting from the
extensive pharmaceutical regulation to which we are subject;
compliance, regulatory and litigation matters, including failure to
comply with complex legal and regulatory environments; other
financial and economic risks; and other factors discussed in our
Annual Report on Form 10-K for the year ended December 31, 2022,
including in the section 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.
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