Findings from the first clinical trial program
comparing the use of Teva’s Digihaler® System to standard of care
in asthma management will be presented across six abstracts
Teva Pharmaceuticals USA, Inc., a U.S. affiliate of Teva
Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA), today
announced that new findings from the CONNECT clinical trial program
assessing the use of the Digihaler System compared to standard of
care (SoC) in asthma management will be presented at the American
College of Allergy, Asthma & Immunology (ACAAI) 2022 Annual
Scientific meeting, being held November 10-14 in Louisville,
Kentucky.
The data will be featured in six posters, three of which will
highlight results from the CONNECT1 clinical trial evaluating the
ProAir® Digihaler (albuterol sulfate) inhalation powder with a
built-in electronic sensor in asthma management versus SoC. Three
additional posters will share the first data from the CONNECT2
clinical trial assessing the joint use of the ProAir Digihaler and
the AirDuo® Digihaler (fluticasone propionate and salmeterol)
inhalation powder with a built-in sensor in asthma management
versus SoC.
“We are looking forward to presenting six abstracts from our
novel CONNECT clinical program assessing the use of the Digihaler
System in asthma management and the potential impact of these
digital health tools on patient-provider interactions, adherence
over time, inhaler technique and frequency of SABA use,” said
Randall Brown, MD MPH, Global Lead, Digital Health, Immunology and
Respiratory Medical Affairs at Teva. “This is the first clinical
trial program to evaluate the Digihaler System and its potential to
support asthma management for patients with uncontrolled asthma
compared to standard of care.”
The Digihaler is a digital health system comprised of an
electronic multidose dry powder smart inhaler, connected app,
Digital Health Platform cloud solution and dashboard that tracks
reliever inhaler usage and inhalation quality as measured by
inspiratory flow to aid in clinical decision-making. 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.
CONNECT1
Initial findings from the CONNECT1 trial were recently presented
at the European Respiratory Society (ERS) International Congress
2022, highlighting the impact of the ProAir Digihaler System on
asthma management compared to standard of care (SoC), and the full
CONNECT1 results were published in the Journal of Allergy and
Clinical Immunology: In Practice following the ERS
presentations.
The three CONNECT1 data sets that will be presented at ACAAI
will highlight:
- The impact the ProAir Digihaler System had on average weekly
and daily SABA use
- An exploratory assessment of use of the ProAir Digihaler System
and inhaler technique maintained over 12 weeks
- Patients’ and clinical staff’s usability experience with the
ProAir Digihaler System
CONNECT2
The CONNECT2 trial was conducted to assess the role of both the
ProAir and AirDuo Digihalers in the treatment of asthma. CONNECT2
was a 24-week open-label, multicenter, randomized, parallel group
study that evaluated the ProAir Digihaler and AirDuo Digihaler and
their impact on asthma management compared to SoC in 427 patients
with asthma. Participants in the SoC group continued treatment with
their current SoC asthma maintenance and reliever medications.
The three CONNECT2 data sets that will be presented at ACAAI
explore:
- The impact of using the Digihaler System on asthma control
- The frequency and type of interactions between patients and
physicians undertaken for asthma management prompted by the use of
the Digihaler System
- How using the Digihaler System may impact adherence to
maintenance treatment
These poster presentations can be accessed by registering for
the meeting.
Teva-sponsored data to be presented includes:
#P097 Effectiveness Of A Maintenance and Reliever Digital
System To Improve Asthma Control (CONNECT2) Session: TBC
Date/Time: Friday, November 11th, 3:45 PM – 4:00 PM
#P098 Data From A Maintenance And Reliever Digital System
Support Patient–Clinician Interactions In Asthma (CONNECT2)
Session: TBC Date/Time: Friday, November 11th, 4:00 PM – 4:15
PM
#P100 Objective Measurement Of Adherence To Asthma Treatment
With A Maintenance and Reliever Digital System (CONNECT2)
Session: TBC Date/Time: Friday, November 11th, 4:15 PM – 4:30
PM
#P096 Short-acting Beta2-agonist Use Reduction Among Patients
With Uncontrolled Asthma Using A Reliever Digital System
(CONNECT1) Session: TBC Date/Time: Friday, November 11th, 4:30
PM – 4:45 PM
#P099 Inhaler Technique Maintenance In Patients With
Uncontrolled Asthma Using A Reliever Digital System (CONNECT1)
Session: TBC Date/Time: Friday, November 11th, 4:45 PM – 5:00
PM
#P101 Usability Scores Of A Reliever Digital System In
Patients With Uncontrolled Asthma (CONNECT1) Session: TBC
Date/Time: Friday, November 11th, 5:00 PM – 5:15 PM
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
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 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
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;
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 third
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.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20221107005119/en/
IR Contacts Ran Meir (267) 468-4475 Yael Ashman +972 (3)
914 8262 PR Contacts Doris Yiu (973) 265-3752 Yonatan Beker
(973) 917-0851
Teva Pharmaceutical Indu... (NYSE:TEVA)
Gráfico Histórico do Ativo
De Fev 2024 até Mar 2024
Teva Pharmaceutical Indu... (NYSE:TEVA)
Gráfico Histórico do Ativo
De Mar 2023 até Mar 2024