[August 07, 2017] |
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Teva Announces FDA Approval of QVAR® RediHaler™ (Beclomethasone Dipropionate HFA) Inhalation Aerosol
Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) announced
today that the U.S. Food and Drug Administration (FDA) has approved QVAR®
RediHaler™ (beclomethasone dipropionate HFA) inhalation aerosol, a
breath-actuated inhaler for the maintenance treatment of asthma as a
prophylactic therapy in patients 4 years of age and older. QVAR®
RediHaler™ is not indicated for the relief of acute bronchospasm. The
product is expected to become commercially available in both 40mcg and
80mcg strengths to patients by prescription during the first quarter of
2018.
QVAR® RediHaler™ differs from conventional metered-dose
inhalers (MDIs) as it delivers medication via a breath-actuated MDI (News - Alert),
eliminating the need for hand-breath coordination during inhalation. QVAR®
RediHaler™ administers the same active drug ingredient found in QVAR®
(beclomethasone dipropionate HFA) Inhalation Aerosol, with a different
mode of delivery. In addition, QVAR® RediHaler™ is designed
to be used without shaking or priming. It should not be used with a
spacer or volume holding chamber.
"When working to manage asthma on a daily basis, proper administration
of medication is of paramount importance," said Dr. Warner W. Carr, MD,
Associate Medical Director of Southern California Research at Allergy
and Asthma Associates of Southern California Medical Group in Mission
Viejo, California. "However, research has indicated that approximately
76 percent of patients still struggle to use their MDI inhalers correctly1,
thus placing them at increased risk for asthma exacerbations. From a
clinical perspective, QVAR® RediHaler™ is a much-needed
treatment option for these patients who may be experiencing continued
difficulty with hand-breath coordination."
"It's important that we uncover new opportunities to take longstanding,
clinically effective medications, such as QVAR®, and
incorporate them into device technologies that may help address key
ongoing issues for patients, including inhaler technique," said Tushar
Shah, MD, Head, Late Stage Development at Teva Pharmaceuticals. "The FDA
approval of QVAR® RediHaler™ brings to market inhaler
technology aimed at enabling patients to more accurately administer the
medication and ensuring they are receiving a proper dose with each
inhalation."
QVAR® MDI with dose counter, the currently available form of
QVAR®, was originally approved by the FDA in 2014. Teva plans
to discontinue sales of this current QVAR® MDI formulation
upon the launch of QVAR® RediHaler™ in the first quarter of
2018. Patients and caregivers are encouraged to speak with a healthcare
professional about how this transition may impact their current
treatment plan.
This approval is supported by Teva's clinical development program for
QVAR® RediHaler™, which includes data from one Phase I and
four Phase III studies that evaluated the safety and efficacy of the
product in asthma patients ages four years and older.
Indication QVAR® RediHaler™ (beclomethasone
dipropionate HFA) Inhalation Aerosol is indicated for the maintenance
treatment of asthma as prophylactic therapy in patients 4 years of age
or older.
Important Limitation of Use: QVAR RediHaler Inhalation Aerosol is NOT
indicated for the relief of acute bronchospasm.
Important Safety Information
-
Contraindications: QVAR RediHaler is contraindicated in:
-
Primary treatment of status asthmaticus or other acute episodes of
asthma where intensive measures are required
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Patients with known hypersensitivity to beclomethasone
dipropionate or any of the ingredients in QVAR RediHaler
-
Localized infections: Infections with Candida albicans have
occurred in the mouth and pharynx in some patients receiving QVAR
RediHaler. Advise rinsing of mouth with water without swallowing after
use. If oropharyngeal candidiasis develops, QVAR RediHaler may need to
be temporarily interrupted under close medical supervision
-
Deterioration of asthma and acute episodes: Do not use QVAR
RediHaler for the relief of acute symptoms. Instruct patients to
contact their physician immediately if episodes of asthma that are not
responsive to bronchodilators occur during the course of treatment
with QVAR RediHaler
-
Transferring Patients from Systemic Corticosteroid Therapy:
Particular care is needed in patients who are transferred from
systemically active corticosteroids to QVAR RediHaler because deaths
due to adrenal insufficiency have occurred in asthmatic patients
during and after transfer from systemic corticosteroids to less
systemically available inhaled corticosteroids. Taper patients slowly
from systemic corticosteroids if transferring to QVAR RediHaler
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Immunosuppression: Patients who are on drugs that suppress the
immune system, such as corticosteroids, are more susceptible to
infections than healthy individuals and should avoid exposure to
chicken pox or measles. Inhaled corticosteroids should be sed with
caution, if at all, in patients with active or quiescent tuberculosis
infection of the respiratory tract; untreated systemic fungal,
bacterial, parasitic, or viral infections; or ocular herpes simplex
-
Paradoxical Bronchospasm: Inhaled corticosteroids may produce
inhalation-induced bronchospasm with an immediate increase in wheezing
after dosing that may be life-threatening. If this occurs with QVAR
RediHaler, it should be treated immediately with an inhaled,
short-acting bronchodilator. Treatment with QVAR RediHaler should be
discontinued and alternate therapy instituted
-
Hypersensitivity reactions: Hypersensitivity reactions, such as
urticaria, angioedema, rash, and bronchospasm, may occur after
administration of QVAR RediHaler. Discontinue QVAR RediHaler if such
reactions occur
-
Hypercorticism and Adrenal Suppression: It is possible that
systemic corticosteroid effects such as hypercorticism and adrenal
suppression may appear in a small number of patients, particularly at
higher than recommended doses. If such changes occur, reduce the QVAR
RediHaler dose slowly, consistent with accepted procedures for
reducing systemic corticosteroids and for management of asthma symptoms
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Effects on Growth: Orally inhaled corticosteroids, including
QVAR RediHaler, may cause a reduction in growth velocity when
administered to pediatric patients. Routinely monitor the growth of
pediatric patients receiving QVAR RediHaler. To minimize the systemic
effects, titrate to the lowest dosage that effectively controls
symptoms
-
Reduction in Bone Mineral Density (BMD): Decreases in bone
mineral density have been observed with long-term administration of
products containing inhaled corticosteroids. Patients with major risk
factors for decreased bone mineral content should be monitored and
treated with established standards of care
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Eye Disorders: Glaucoma, increased intraocular pressure,
blurred vision and cataracts have been reported following the
long-term administration of inhaled corticosteroids. Therefore, close
monitoring is warranted in patients with a change in vision or with a
history of increased intraocular pressure, blurred vision, glaucoma,
and/or cataracts
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Adverse Reactions: Most common adverse reactions (incidence =3%
and >placebo) include oral candidiasis, upper respiratory tract
infection, nasopharyngitis, allergic rhinitis, oropharyngeal pain and
sinusitis.
Please click here for full Prescribing Information: 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 [email protected]
or Teva's Public Relations or Investor Relations contacts.
About Teva Respiratory Teva Respiratory develops and
delivers 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 1,800
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 2015 amounted to $19.7 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 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: 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. American Thoracic Society, Rescue Inhaler Study: New Approach
Increases Mastery of Life-Saving Technique, March 18, 2016. Available
at: https://www.thoracic.org/about/newsroom/press-releases/journal/rescue-inhaler-study-new-approach-increases-mastery-of-life-saving-technique.php.
Accessed on May 25, 2016.
View source version on businesswire.com: http://www.businesswire.com/news/home/20170807005360/en/
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