Teva Announces U.S. Launch of QVAR® RediHaler™ (Beclomethasone Dipropionate HFA) Inhalation Aerosol
February 12 2018 - 8:00AM
Business Wire
First and Only Breath-Actuated Aerosol Inhaled
Corticosteroid in the United States Designed to Help Eliminate the
Need for Hand-Breath Coordination
Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA)
announced today that QVAR® RediHaler™ (beclomethasone dipropionate
HFA) Inhalation Aerosol is now commercially available to patients
in both 40 mcg and 80 mcg strengths by prescription in the U.S.
QVAR® RediHaler™ is the first and only breath-actuated aerosol
inhaled corticosteroid for the maintenance treatment of asthma as a
prophylactic therapy in patients 4 years of age and older. It is
not indicated for the relief of acute bronchospasm.
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the full release here:
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QVAR® RediHaler™ product image (Photo:
Business Wire)
“When it comes to the treatment of asthma, proper inhaler
technique remains a critical issue for patients. In fact, nearly 68
percent of patients do not use their metered dose inhalers (MDIs)
well enough to benefit from the prescribed medication1, leading to
potentially uncontrolled asthma symptoms2,” said Dr. Warner W.
Carr, MD, Associate Medical Director of Southern California
Research at Allergy and Asthma Associates of Southern California
Medical Group. “As a physician, it’s often a challenge to know if
my patients are using their inhalers correctly once they leave the
office. It’s reassuring to see new device technologies come to
market, such as the QVAR® RediHaler™ device, which is designed
specifically to eliminate the need for hand-breath
coordination.”
QVAR® RediHaler™ differs from conventional metered-dose inhalers
(MDIs) as it delivers medication via a breath-actuated inhaler,
eliminating the need for hand-breath coordination during
inhalation. QVAR® RediHaler™ administers the same active ingredient
found in the previously available QVAR® (beclomethasone
dipropionate HFA) Inhalation Aerosol, but utilizes innovative
breath-actuated inhaler technology. QVAR® RediHaler™ was also
designed to be ready for use, with no shaking or priming needed.
Because the medication delivery is breath actuated, it should not
be used with a spacer or volume holding chamber.
“QVAR® has been an available asthma treatment option for well
over a decade, so we are excited by the new technology of QVAR®
RediHaler™ that directly addresses an unmet need in the field of
asthma management,” said Brendan O’Grady, Executive Vice President,
North America Commercial at Teva. “By merging our breath-actuated
inhaler technology with asthma medication, we hope to better serve
the needs of the respiratory community and look forward to seeing
the adoption of QVAR® RediHaler™ in the coming months.”
With the launch of QVAR® RediHaler™, Teva is discontinuing sales
of the previously available QVAR®. Patients currently prescribed
QVAR® and/or their caregivers are encouraged to speak with a
healthcare professional about how this new treatment option may
impact their treatment plan and how to obtain and use QVAR®
RediHaler™, if desired. QVAR® RediHaler™ will be priced at parity
to QVAR®.
Approved Use
QVAR® RediHaler™ (beclomethasone dipropionate HFA) Inhalation
Aerosol is a breath-actuated inhaled prescription medicine used as
a maintenance treatment for the prevention and control of asthma in
people 4 years of age and older.
QVAR® RediHaler™ Inhalation Aerosol is not used to relieve
sudden breathing problems and won’t replace a rescue inhaler.
Important Safety Information
- Do not use QVAR® RediHaler™ to treat
sudden severe symptoms of asthma. Always have a rescue inhaler with
you to treat sudden symptoms.
- Do not use QVAR® RediHaler™ if you are
allergic to beclomethasone dipropionate or any of the ingredients
in QVAR® RediHaler™.
- Do not use QVAR® RediHaler™ more
often than prescribed.
- Tell your healthcare provider about
all the medicines you take and about all of your health
conditions.
- QVAR®
RediHaler™ may cause serious side effects,
including:
- Fungal infections
(thrush) in your mouth and throat. Rinse your mouth
with water without swallowing after using QVAR® RediHaler™
to help prevent an infection in your mouth or throat.
- Worsening asthma or sudden asthma
attacks. After using your rescue inhaler, contact your
healthcare provider right away if you do not get relief from your
sudden asthma attacks
- Reduced adrenal function (adrenal
insufficiency). This potentially life-threatening
condition can happen when you stop taking oral corticosteroid
medicines and start using inhaled corticosteroid medicines (such as
QVAR® RediHaler™). Tell your healthcare provider right away about
any signs and symptoms of adrenal insufficiency such as: feeling
tired or exhausted (fatigue); lack of energy; low blood pressure
(hypotension); dizziness or feeling faint; nausea and vomiting; or
weakness
- Immune system effects and a higher
chance for infections. Tell your healthcare provider about any
signs or symptoms of infection such as: fever, chills, pain,
feeling tired, body aches, nausea, or vomiting
- Increased wheezing (bronchospasm)
right after using QVAR® RediHaler™.
Always have a rescue inhaler with you to treat sudden
wheezing.
- Serious allergic
reactions. Stop using QVAR® RediHaler™ and call your
healthcare provider or get emergency medical help right away if you
get any of the following: hives; swelling of your lips, tongue, or
face; rash; or breathing problems
- Slowed growth in
children. Children should have their growth checked
regularly while using QVAR® RediHaler™.
- Lower bone density. This may be
a problem for people who already have a higher chance for low bone
density (osteoporosis).
- Eye problems. If you have had
glaucoma, cataracts or blurred vision in the past, you should have
regular eye exams while using QVAR® RediHaler™.
- Common side effects of
QVAR® RediHaler™ include: yeast
infection in the mouth (oral candidiasis); cold symptoms (upper
respiratory tract infection); pain in the throat (oropharyngeal
pain); pain or swelling in your nose and throat (nasopharyngitis);
sinus irritation (sinusitis); and hay fever (allergic
rhinitis)
- These are not all the possible side
effects of QVAR® RediHaler™. Call your doctor for medical advice
about side effects. You may report side effects to FDA at
1-800-FDA-1088.
Please see full Prescribing Information at
http://www.qvarredihaler.com/Pdf/PI.pdf
A copy may be requested from the US Medical Information Contact
Center for Teva Specialty Medicines at 888-4-TEVA-RX (888-483-8279)
and USMedInfo@tevapharm.com or Teva’s Public Relations or Investor
Relations contacts.
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
1,800 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 2017 were $22.4 billion. For
more information, visit 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 the U.S. launch of QVAR® RediHaler™, 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 potential benefits and uncertainty
of commercial success of QVAR® RediHaler™;
- our specialty medicines business,
including: competition for our specialty products, especially
Copaxone®, our leading medicine, which faces competition from
existing and potential additional generic versions and
orally-administered alternatives; challenges inherent in product
research and development, uncertainty of clinical success and
obtaining regulatory approvals as well as our ability to achieve
expected results from investments in our product pipeline;
competition from companies with greater resources and capabilities;
and the effectiveness of our patents and other measures to protect
our intellectual property rights;
- our business and operations in general,
including: failure to effectively execute the recently announced
restructuring plan; uncertainties relating to the potential
benefits and success of our new organizational structure and recent
senior management changes; our ability to develop and commercialize
additional pharmaceutical products; manufacturing or quality
control problems, which may damage our reputation for quality
production and require costly remediation; interruptions in our
supply chain; disruptions of our or third party information
technology systems or breaches of our data security; the
restructuring of our manufacturing network, including potential
related labor unrest; the impact of continuing consolidation of our
distributors and customers; and variations in patent laws that may
adversely affect our ability to manufacture our products;
- compliance, regulatory and litigation
matters, including: costs and delays resulting from the extensive
governmental regulation to which we are subject; the effects of
reforms in healthcare regulation and reductions in pharmaceutical
pricing, reimbursement and coverage; potential additional adverse
consequences following our resolution with the U.S. government of
our FCPA investigation; governmental investigations into sales and
marketing practices; potential liability for sales of generic
products prior to a final resolution of outstanding patent
litigation; product liability claims; increased government scrutiny
of our patent settlement agreements; failure to comply with
complex Medicare and Medicaid reporting and payment
obligations; and environmental risks; and other factors discussed
in our Annual Report on Form 20-F for the year ended December
31, 2016 (“Annual Report”), including in the section captioned
“Risk Factors,” and in our other filings with the U.S.
Securities and Exchange Commission, which are available at
www.sec.gov and www.tevapharm.com. 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. Fink JB, Rubin BK. Problems with inhaler use: a call for
improved clinician and patient education. Respir Care.
2005;50(10):1360-1374.2. D. Price, S. Bosnic-Anticevich, A. Briggs,
H. Chrystyn, C. Rand, G. Scheuch, J. Bousquet. Inhaler competence
in asthma:Common errors, barriers to use and recommended solutions.
Respiratory Medicine. 2013; 107:37-46.
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version on businesswire.com: http://www.businesswire.com/news/home/20180212005322/en/
Teva Pharmaceutical Industries Ltd.IR Contacts:United
StatesKevin C. Mannix, 215- 591-8912Ran Meir,
215-591-3033orIsraelTomer Amitai, 972 (3) 926-7656orPR
Contacts:IsraelYonatan Beker, 972 (54) 888-5898orUnited
StatesKaelan Hollon, 202-412-7076Michelle Larkin,
610-786-7335
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