Teva to Present Findings on Short-Acting Beta Agonist (SABA) Use in Asthma Patients and the Potential of ProAir® Digihaler® (albuterol sulfate) Inhalation Powder to Help Inform Treatment Decisions at American Thoracic Society 2022 Annual Meeting
12 Mai 2022 - 2:00PM
Business Wire
Late-breaking abstract will highlight the
application of independent expert consensus thresholds for SABA use
to an asthma patient cohort whose daily SABA use was reliably
recorded via a digital platform
Teva Pharmaceuticals USA, Inc., a U.S. affiliate of Teva
Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA), today
announced new findings will be presented at the 2022 American
Thoracic Society (ATS) 2022 Annual Meeting that apply clinical
thresholds for short-acting beta agonist (SABA) use established by
independent expert consensus to objective patient data from ProAir
Digihaler (albuterol sulfate) Inhalation Powder. These findings are
the first to examine daily SABA usage captured by the ProAir
Digihaler based on the clinical thresholds and will be presented in
a late-breaker oral session at the 2022 ATS Annual Meeting, taking
place on May 13-18, 2022, in San Francisco.
“Asthma is a common and serious chronic lung disease that
affects the airways, which can make breathing difficult.1 SABA
inhalers are used to get treatment to the lungs quickly during an
exacerbation or asthma attack, but its overuse is associated with
poorly controlled asthma and other adverse outcomes,”2 said Tanisha
Hill, Senior Medical Director, Respiratory at Teva. “Our latest
data at ATS will showcase how objective data from ProAir Digihaler,
an FDA-approved reliever medication with a built-in sensor, could
help capture reliable reliever usage and inhaler event data that
physicians and their patients can use to help support informed
treatment discussions and assessments.”
This presentation can be accessed by registering for the
meeting.
Teva-sponsored data to be presented include:
Application of Modified Delphi Expert Consensus Thresholds on
SABA Reliever Use in Asthma to Data Obtained from a 12-Week Study
of a Digital Inhaler in Sub-Optimally Controlled Asthma
Patients Session: B14 Old Dogs New Tricks: Late-Breaking
Abstracts in Obstructive Lung Disease Date/Time: Monday, May 16th,
10:00 AM – 10:10 AM
About ProAir Digihaler The Digihaler Inhalers are the
first family of smart inhalers with built-in sensors that capture
personal inhaler data and allow patients to track and share their
data. ProAir Digihaler (albuterol sulfate) Inhalation Powder is the
first and only breath-actuated, digital short-acting beta agonist
(SABA) inhaler with built-in flow sensors that detect, record and
store objective data showing how often and how well patients use
their rescue inhaler, as measured by inspiratory flow. Patients are
able to view their personalized data on the Digihaler® app and can
share it with a healthcare provider to inform their asthma
treatment plan, facilitate dialogue and guide decisions around
treatment adjustments. This personal inhaler data can record how
well a patient uses their inhaler by measuring the strength of
inhalations, indicating when inhaler technique may need
improvement. In addition, the data can capture rescue inhaler user
patterns over time and show trends indicating when increasing SABA
use might be associated with disease worsening.
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.
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, 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 digital inhalers portfolio, including
ProAir Digihaler; our ability to successfully compete in the
marketplace, including our ability to develop and commercialize
biopharmaceutical products, competition for our specialty products,
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
uncertainty regarding the COVID-19 pandemic and the governmental
and societal responses thereto; 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; costs and delays resulting from the
extensive pharmaceutical regulation to which we are subject or
delays in governmental processing time due to travel and work
restrictions caused by the COVID-19 pandemic; 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 Quarterly Report
on Form 10-Q for the first quarter of 2022 and in our Annual Report
on Form 10-K for the year ended December 31, 2021, 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.
1 National Heart, Lung, and Blood Institute. What is Asthma?
Available at: www.nhlbi.nih.gov/health/asthma. Accessed: April 19,
2022. 2 Tavakoli H, Mark FitzGerald J, Lynd LD, Sadatsafavi M.
Predictors of inappropriate and excessive use of reliever
medications in asthma: a 16-year population-based study. BMC Pulm
Med. 2018;18(1):33. doi:10.1186/s12890-018-0598-4
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