Teva Announces FDA Approval of ProAir RespiClick® (albuterol sulfate) Inhalation Powder for Pediatric Asthma Patients Ages 4...
29 Avril 2016 - 2:00PM
Business Wire
New Pediatric Indication Provides Treatment
Option for Children that Eliminates Need for Spacer and Hand-Breath
Coordination During Inhalation
Teva Pharmaceutical Industries Ltd., (NYSE and TASE: TEVA)
announced today that the U.S. Food and Drug Administration (FDA)
has approved ProAir RespiClick® (albuterol sulfate) Inhalation
Powder for the treatment or prevention of bronchospasm in children
4 to 11 years of age with reversible obstructive airway disease and
for the prevention of exercise-induced bronchospasm (EIB).
ProAir RespiClick® was approved by the FDA for use in patients
12 years of age and older in March 2015 and remains the only
breath-activated, multi-dose, dry powder, short-acting beta-agonist
(SABA) inhaler available in the U.S.
“The prevalence of childhood asthma in the U.S. is high, at more
than six million patients, and that number continues to rise,” said
Dr. Erwin Gelfand, Chairman, Department of Pediatrics at National
Jewish Health. “For this young population of asthma patients,
learning to use inhalers properly can be quite challenging. Thus,
the pediatric indication for ProAir RespiClick® is important as it
represents a new rescue inhaler option for younger patients that
eliminates the need for hand-breath coordination during inhalation
and was designed to be used without a spacer.”
The pediatric approval of ProAir RespiClick® comes after the
FDA’s review of data from Teva’s Phase III clinical trial program
that evaluated the safety and efficacy of the treatment in patients
as young as four years of age, living with asthma. The data
demonstrated that treatment with ProAir RespiClick® resulted in
significantly greater improvement in forced expiratory volume
(FEV1) compared to placebo. The most common adverse events
associated with treatment with ProAir RespiClick® included upper
respiratory infections, mouth and throat pain and vomiting.
“We are very pleased with the FDA’s decision to expand the
indication of ProAir RespiClick® for the treatment of patients as
young as four years of age,” said Tushar Shah, MD, Senior Vice
President, Teva Global Respiratory Research and Development. “The
availability of this treatment option for younger patients is a
demonstration of Teva’s commitment to optimizing respiratory
therapies through the development of new delivery systems that help
address needs in the marketplace.”
Approved Uses
ProAir RespiClick® (albuterol sulfate) Inhalation Powder is
indicated in patients 4 years of age and older for the treatment or
prevention of bronchospasm with reversible obstructive airway
disease and for the prevention of exercise-induced
bronchospasm.
Important Safety Information
- Do not use ProAir RespiClick®
(albuterol sulfate) Inhalation Powder if you are allergic to
albuterol sulfate, lactose, or milk proteins. Call your doctor
right away if you develop red, itchy bumps on your skin, swelling
beneath your skin or in your throat, rash or worsening trouble
breathing
- If your symptoms become significantly
worse when you use ProAir RespiClick®, seek medical attention
immediately. This may indicate either a worsening of your asthma or
a reaction to the medication. Either of these could be
life-threatening
- Do not increase your dose or
take extra doses of ProAir RespiClick® without first talking to
your healthcare professional
- Before using ProAir RespiClick®, be
sure to tell your healthcare professional if you have a heart,
blood, thyroid or seizure disorder, high blood pressure, diabetes,
are pregnant or planning to become pregnant, or are breastfeeding
or planning to breastfeed
- ProAir RespiClick® can cause
significant heart-related side effects, such as an increase in
pulse, blood pressure and/or related symptoms. If you have a heart
condition, your healthcare professional will determine if ProAir
RespiClick® is right for you
- Make sure your healthcare professional
knows all the medicines you are taking – especially other inhaled
medicines, other asthma medicines, heart and blood pressure
medicines and drugs that treat depression – because some medicines
may interfere with how well your asthma medicines work
- Common side effects in patients 12
years of age and older taking ProAir RespiClick® include back pain,
body aches and pains, upset stomach, sinus headache, and urinary
tract infection
- Common side effects in patients 4 to 11
years of age taking ProAir RespiClick® include upper respiratory
infections, mouth and throat pain, and vomiting
- Tell your healthcare provider if you
have any side effect that bothers you or that does not go away
- These are not all of the possible side
effects of ProAir RespiClick®. For more information, ask your
healthcare provider or pharmacist
- 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 click here for Full Prescribing Information
About Teva Respiratory
Teva Respiratory develops and delivers high-quality treatment
options for respiratory conditions, including asthma, COPD and
allergic rhinitis. The Teva Respiratory portfolio is centered on
optimizing respiratory treatment for patients and healthcare
providers through the development of novel delivery systems and
therapies that help address unmet needs. The company’s respiratory
pipeline and clinical trial program are based on drug molecules
delivered in proprietary dry powder formulations and
breath-actuated device technologies, as well as a targeted biologic
treatment for severe asthma. Through research and clinical
development, Teva Respiratory continually works to expand,
strengthen and build upon its treatment portfolio to positively
impact the lives of the millions of patients living with
respiratory disease.
About Teva
Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) is a
leading global pharmaceutical company that delivers high-quality,
patient-centric healthcare solutions used by millions of patients
every day. Headquartered in Israel, Teva is the world’s largest
generic medicines producer, leveraging its portfolio of more than
1,000 molecules to produce a wide range of generic products in
nearly every therapeutic area. In specialty medicines, Teva has a
world-leading position in innovative treatments for disorders of
the central nervous system, including pain, as well as a strong
portfolio of respiratory products. Teva integrates its generics and
specialty capabilities in its global research and development
division to create new ways of addressing unmet patient needs by
combining drug development capabilities with devices, services and
technologies. Teva's net revenues in 2015 amounted to $19.7
billion. For more information, visit www.tevapharm.com.
Teva's Safe Harbor Statement under the U. S. Private
Securities Litigation Reform Act of 1995:
This release contains forward-looking statements, which are
based on management’s current beliefs and expectations and involve
a number of known and unknown risks and uncertainties that could
cause our future results, performance or achievements to differ
significantly from the results, performance or achievements
expressed or implied by such forward-looking statements. Important
factors that could cause or contribute to such differences include
risks relating to: our ability to develop and commercialize
additional pharmaceutical products; competition for our specialty
products, especially Copaxone® (which faces competition from
orally-administered alternatives and a generic version); our
ability to consummate the acquisition of Allergan plc’s worldwide
generic pharmaceuticals business (“Actavis Generics”) and to
realize the anticipated benefits of such acquisition (and the
timing of realizing such benefits); the fact that following the
consummation of the Actavis Generics acquisition, we will be
dependent to a much larger extent than previously on our generic
pharmaceutical business; potential restrictions on our ability to
engage in additional transactions or incur additional indebtedness
as a result of the substantial amount of debt we will incur to
finance the Actavis Generics acquisition; the fact that for a
period of time following the consummation of the Actavis Generics
acquisition, we will have significantly less cash on hand than
previously, which could adversely affect our ability to grow; the
possibility of material fines, penalties and other sanctions and
other adverse consequences arising out of our ongoing FCPA
investigations and related matters; our ability to achieve expected
results from investments in our pipeline of specialty and other
products; our ability to identify and successfully bid for suitable
acquisition targets or licensing opportunities, or to consummate
and integrate acquisitions; the extent to which any manufacturing
or quality control problems damage our reputation for quality
production and require costly remediation; increased government
scrutiny in both the U.S. and Europe of our patent settlement
agreements; our exposure to currency fluctuations and restrictions
as well as credit risks; the effectiveness of our patents,
confidentiality agreements and other measures to protect the
intellectual property rights of our specialty medicines; the
effects of reforms in healthcare regulation and pharmaceutical
pricing, reimbursement and coverage; competition for our generic
products, both from other pharmaceutical companies and as a result
of increased governmental pricing pressures; governmental
investigations into sales and marketing practices, particularly for
our specialty pharmaceutical products; adverse effects of political
or economic instability, major hostilities or acts of terrorism on
our significant worldwide operations; interruptions in our supply
chain or problems with internal or third-party information
technology systems that adversely affect our complex manufacturing
processes; significant disruptions of our information technology
systems or breaches of our data security; competition for our
specialty pharmaceutical businesses from companies with greater
resources and capabilities; the impact of continuing consolidation
of our distributors and customers; decreased opportunities to
obtain U.S. market exclusivity for significant new generic
products; potential liability in the U.S., Europe and other markets
for sales of generic products prior to a final resolution of
outstanding patent litigation; our potential exposure to product
liability claims that are not covered by insurance; any failure to
recruit or retain key personnel, or to attract additional executive
and managerial talent; any failures to comply with complex Medicare
and Medicaid reporting and payment obligations; significant
impairment charges relating to intangible assets, goodwill and
property, plant and equipment; the effects of increased leverage
and our resulting reliance on access to the capital markets;
potentially significant increases in tax liabilities; 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; variations in patent laws that may adversely affect our
ability to manufacture our products in the most efficient manner;
environmental risks; and other factors that are discussed in our
Annual Report on Form 20-F for the year ended December 31, 2015 and
in our other filings with the U.S. Securities and Exchange
Commission (the "SEC"). 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, whether as a result of new information, future events
or otherwise.
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Teva Pharmaceutical Industries Ltd.:IR:Kevin C. Mannix,
215-591-8912United StatesorRan Meir , 215-591-3033United
StatesorTomer Amitai, 972 (3) 926-7656IsraelorPR:Iris
Beck Codner, 972 (3) 926-7687IsraelorDenise Bradley,
215-591-8974United StatesorNancy Leone, 215-284-0213United
States
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