Teva Announces New Findings Highlighting Potential of ProAir® Digihaler® (albuterol sulfate) Inhalation Powder to Address Asthma Treatment Challenges
17 Mai 2022 - 1:45PM
Business Wire
Results were presented in a late-breaking oral
session at the ATS 2022 annual meeting
Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical
Industries Ltd. (NYSE and TASE: TEVA), announced new study findings
based on newly established clinical thresholds on short-acting beta
agonist (SABA) use that highlight real-world SABA usage among
patients with asthma in the U.S. and the potential for ProAir®
Digihaler® (albuterol sulfate) inhalation powder, a digital
inhaler, to help inform treatment discussions and decisions. The
findings were presented in a late-breaking oral session at the
American Thoracic Society (ATS) 2022 Annual Meeting.
Among the study findings, nearly one-third of asthma patients
made 138 or more inhalations during the 12-week study period, which
was equivalent to 600 or more inhalations, or three or more
canisters, per year. In this study analysis, valid inhalations are
defined as events when the patient inhales at a peak inspiratory
flow (PIF) rate between >18 to <120 liters/minute with no
errors in use. The findings are the first application of
evidence-based clinical statements from an independent U.S. expert
consensus that identify risk of asthma exacerbation, including
potential for a life-threatening event, based on patients’ SABA
overuse. These results suggest digital inhalers may help healthcare
professionals identify and address SABA reliever overuse and help
inform clinical decision-making based on individual insights from
objective patient SABA reliever usage data downloaded directly from
their ProAir Digihaler.
“These findings shed important light on patients’ real-world use
of SABA and the potential of objective data from digital health
tools like ProAir Digihaler to help inform treatment decisions,”
said Tanisha Hill, Senior Medical Director, Respiratory and Digital
Health Medical Lead at Teva. “The findings suggest that, with
ProAir Digihaler, accurate and objective data on reliever inhaler
use can help facilitate treatment discussions between providers and
patients.”
“Many patients with poorly controlled asthma rely on SABA when
they have an asthma exacerbation,” said Njira Lugogo, MD, Clinical
Associate Professor, University of Michigan, and lead study author.
“Our research shows that there is a gap between clinical
recommendations and real-world management of asthma, and shows how
digital tools, such as ProAir Digihaler, may help address some of
these challenges.”
Data on SABA usage among 359 patients downloaded from ProAir
Digihaler devices were used to apply and validate clinical action
thresholds for risk associated with SABA reliever overuse
established by independent expert consensus. Patients made one or
more valid inhalations (PIF >18 to <120 with no errors in
use) from a ProAir Digihaler device over a 12-week period. Elevated
SABA use among sub-optimally controlled asthma patients was found
to be more common than previously understood.1 Detailed results
include:
- 89% (319/359) of patients met the consensus threshold of SABA
reliever medication use that is ≥100% over baseline during one or
more study weeks, and 72% (260/359) met the threshold of SABA
reliever medication use ≥200% above baseline. These thresholds were
determined by independent consensus to likely indicate impending or
ongoing exacerbation.1
- 17% (62/359) of patients made 25 or more valid inhalations in a
week, a level associated with unanimous consensus of likely
impending or ongoing exacerbation.1 This included 14% (40/295) of
patients who did not have a confirmed exacerbation.1
- Nearly one-third of patients (29%, 104/359) exhibited a rate of
SABA reliever use over 12 weeks equivalent to three or more
canisters per year, which was determined by consensus to be
associated with increased risk of asthma exacerbation and death.1
This included 52% (33/64) of patients who had asthma exacerbations
during the study period, and 24% (71/295) who did not have
confirmed exacerbations.1
About ProAir Digihaler
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.
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.
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,
biosimilar 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 Lugogo N, Oppenheimer J, Merchant R, et al. Application of
Modified Delphi Expert Consensus Thresholds on SABA Reliever Use in
Asthma to Date Obtained From a 12-week Study of a Digital Inhaler
in Suboptimally Controlled Asthma Patients. Abstract presented at
2022 American Thoracic Society Annual Meeting, May 13-18, San
Francisco, CA.
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