Teva to Highlight Research in Respiratory Care at Upcoming 2021 American Thoracic Society International Conference
May 10 2021 - 8:00AM
Business Wire
Two e-posters include new data across asthma
and chronic obstructive pulmonary disease (COPD), emphasizing
Teva’s commitment to patients with respiratory diseases
Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical
Industries Ltd. (NYSE and TASE: TEVA), today announced that it will
present two new e-posters at the upcoming American Thoracic Society
(ATS) International Conference, taking place virtually May 14-19,
2021. One of the two e-posters details data on increased
short-acting beta-agonist (SABA) use in patients with poorly
controlled asthma, as measured by Teva’s ProAir® Digihaler®
(albuterol sulfate) inhalation powder, a SABA inhaler prescribed to
people 4 years of age and older to treat or prevent bronchospasm in
people who have reversible obstructive airway disease or prevent
exercise-induced bronchospasm, that automatically detects, records,
and stores data on inhaler events. The second e-poster includes
data on real-world uncontrolled COPD therapy.
“Teva is proud of the analyses being presented at this year’s
ATS meeting, which underscore our commitment to the respiratory
disease community,” said Danny McBryan, MD, Head of Global Medical
Affairs & Pharmacovigilance, at Teva Pharmaceuticals. “The
ProAir® Digihaler® findings are particularly exciting as the data
collected by the electronic sensor embedded within the device
provides objective inhaler use data that can be used to help inform
treatment decisions in the management of patients who suffer from
asthma and acute symptoms of COPD.”
The following e-posters, accompanied with an audio file
featuring the studies’ authors, will be available online at the
start of the meeting on May 14, 2021 and can be accessed via the
ATS meeting website at www.conference.thoracic.org. Additionally,
abstracts presented at the virtual conference were published in the
Online Abstract Issue of the American Journal of Respiratory and
Critical Care Medicine, Volume 203, May 3, 2021.
- Abstract A1459 - Short-acting beta-agonist bursts and
overuse in patients with poorly controlled asthma, as recorded by a
digital inhaler
- This analysis aimed to identify SABA bursts and SABA overuse in
patients with asthma using the ProAir® Digihaler®.
- Abstract A2259 - Assessing Real-World Uncontrolled COPD
Therapy Using a US Administrative Claims Database
- This study evaluated real-world administrative claims data to
assess increased SABA and systemic corticosteroid use in patients
with COPD as an indicator of “uncontrolled disease or suboptimal
therapy.”
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 Dighaler 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
regarding ProAir® 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 our 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; delays in launches of new generic
products; the increase in the number of competitors targeting
generic opportunities and seeking U.S. market exclusivity for
generic versions of significant products; 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, 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: uncertainty
regarding the COVID-19 pandemic and its impact on our business,
financial condition, operations, cash flows, and liquidity and on
the economy in general; 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; effectiveness of our optimization
efforts; our ability to attract, hire and retain highly skilled
personnel; 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 political or economic instability, major hostilities or
terrorism; 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; the effects of reforms in
healthcare regulation and reductions in pharmaceutical pricing,
reimbursement and coverage; 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; and our prospects and opportunities for
growth if we sell assets;
- compliance, regulatory and litigation matters, including:
failure to comply with complex legal and regulatory environments;
increased legal and regulatory action in connection with public
concern over the abuse of opioid medications and our ability to
reach a final resolution of the remaining opioid-related
litigation; scrutiny from competition and pricing authorities
around the world, including our ability to successfully defend
against the U.S. Department of Justice criminal charges of Sherman
Act violations; potential liability for patent infringement;
product liability claims; failure to comply with complex Medicare
and Medicaid reporting and payment obligations; compliance with
anti-corruption sanctions and trade control laws; 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 (including as a result of
potential tax reform in the United States); 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 this press release, in our
Quarterly Reports on Form 10-Q for the first quarter of 2021 and in
our Annual Report on Form 10-K for the year ended December 31,
2020, 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.
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