New Biologic for Add-On Maintenance Treatment in Adults with Severe
Asthma and an Eosinophilic Phenotype
JERUSALEM--(BUSINESS WIRE)--Mar. 23, 2016--
Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) today
announced that the U.S. Food and Drug Administration (FDA) has approved
CINQAIR® (reslizumab) Injection, an interleukin 5 antagonist monoclonal
antibody (IgG4 kappa) indicated for add-on maintenance treatment of
patients with severe asthma aged 18 years and older, and with an
eosinophilic phenotype.
CINQAIR® is administered by intravenous (IV) infusion at a weight-based
dose of 3 mg/kg once every four weeks. The treatment is expected to
become commercially available to patients, by prescription, during the
second quarter of 2016.
“Despite ongoing treatment with today’s standard of care, many patients
with severe asthma remain inadequately controlled, the implications of
which can lead to increased exacerbations and hospitalization,” said
Professor Mario Castro, Washington University School of Medicine,
Division of Pulmonary and Critical Care Medicine and lead investigator.
“The approval of CINQAIR® marks an important advancement in the
treatment paradigm for asthma as the therapy has demonstrated
significant improvement in multiple measures of asthma control. As a
practicing physician, I look forward to the opportunity to provide my
patients, who have severe uncontrolled asthma and fit the profile for
CINQAIR®, with an option that has the potential to help them achieve
control of their disease.”
“Teva’s specialty medicines pipeline is centered on developing therapies
to address the unmet needs of patients, healthcare providers,
caregivers, and payers in our key therapeutic areas of focus,” said
Michael Hayden, M.D., Ph.D., President of Global R&D and Chief
Scientific Officer at Teva. “We are proud to demonstrate our commitment
to advancing the treatment of respiratory disease with the development
of CINQAIR®, a targeted therapy for a specific subset of patients with
severe asthma, a disease which can present significant treatment
challenges that are not adequately addressed by currently available
medicines.”
The FDA approval of CINQAIR® was based on review of efficacy and safety
data from Teva’s global development program in asthma. The clinical
trial program consisted of five placebo-controlled studies which
demonstrated the efficacy and safety profile in a population of 1,028
adult and adolescent asthma patients treated with CINQAIR® 3
mg/kg that were inadequately controlled with inhaled corticosteroid
(ICS)-based therapies. Three of these studies constituted the Phase III
program in patients with asthma and elevated blood eosinophils. They
demonstrated that treatment with CINQAIR® was associated with
reduction in asthma exacerbations of up to 59% as well as significant
improvement in lung function, symptoms, and asthma-related quality of
life. The most common adverse reaction (incidence greater than or equal
to two percent) in patients treated with CINQAIR® was
oropharyngeal pain. Anaphylaxis was reported at a rate of 0.3% in the
placebo-controlled studies (n=1028). An imbalance in malignancy was
observed in the Phase III trials (CINQAIR® 0.6% and placebo
0.3%). The observed malignancies were diverse in nature and were
diagnosed within less than six months of exposure to CINQAIR®.
“Teva is committed to delivering innovations in asthma care to help
patients, across the spectrum of this heterogeneous disease, achieve
improved symptom control and quality of life,” said Rob Koremans, M.D.,
President and CEO of Teva Global Specialty Medicines. “We are pleased to
expand our growing respiratory portfolio with CINQAIR® in the U.S. With
this therapy, we now have the ability to provide a targeted, new
treatment option for an underserved patient group, thus helping to
address a major unmet need in asthma management.”
Upon commercial availability of CINQAIR®, Teva will launch
Teva Support Solutions℠, a comprehensive program that will
provide personalized support, training and education to healthcare
providers and patients who have been prescribed CINQAIR®.
This is the first approval of CINQAIR® (reslizumab) anywhere
in the world. Reslizumab has been submitted to and is currently under
review by European Medicines Agency (EMA) and Health Canada.
Indications and Usage
CINQAIR® (reslizumab) is an interleukin 5 antagonist monoclonal antibody
(IgG4 Kappa) indicated for add-on maintenance treatment of patients with
severe asthma aged 18 years and older, with an eosinophilic phenotype.
Limitations of Use: CINQAIR® is not
indicated for treatment of other eosinophilic conditions or relief of
acute bronchospasm or status asthmaticus.
Important Safety Information
WARNING: ANAPHYLAXIS
Anaphylaxis has been observed with CINQAIR infusion in 0.3% of
patients in placebo-controlled clinical studies. Anaphylaxis was
reported as early as the second dose of CINQAIR.
Anaphylaxis can be life-threatening. Patients should be observed for
an appropriate period of time after CINQAIR administration by a
healthcare professional prepared to manage anaphylaxis. Discontinue
CINQAIR immediately if the patient experiences signs or symptoms of
anaphylaxis.
CINQAIR is contraindicated in patients who have known hypersensitivity
to reslizumab or any of its excipients.
In placebo-controlled clinical studies, 6/1028 (0.6%) patients receiving
3 mg/kg CINQAIR had at least 1 malignant neoplasm reported compared to
2/730 (0.3%) patients in the placebo group.
No clinical studies have been conducted to assess reduction of
maintenance corticosteroid dosages following administration of CINQAIR.
Do not discontinue systemic or inhaled corticosteroids abruptly upon
initiation of therapy with CINQAIR. Reductions in corticosteroid dose,
if appropriate, should be gradual and performed under the supervision of
a physician. Reduction in corticosteroid dose may be associated with
systemic withdrawal symptoms and/or unmask conditions previously
suppressed by systemic corticosteroid therapy.
Eosinophils may be involved in the immunological response to some
parasitic (helminth) infections. Treat patients with pre-existing
helminth infections before initiating CINQAIR. If patients become
infected while receiving treatment with CINQAIR and do not respond to
anti-helminth treatment, discontinue treatment with CINQAIR until
infection resolves.
Adverse reactions that occurred at greater than or equal to 2% incidence
and more commonly than in the placebo group included 1 event:
oropharyngeal pain (2.6% vs. 2.2%).
Please click here for full Prescribing Information, including Boxed
Warning: http://www.cinqair.com/pdf/PrescribingInformation.pdf.
Prior to the availability of full Prescribing Information online, 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 CINQAIR® (reslizumab) Injection
CINQAIR® is a humanized interleukin-5 (IL-5) antagonist
monoclonal antibody (IgG4 kappa), approved by the U.S. Food and Drug
Administration (FDA) for add-on maintenance treatment of patients with
severe asthma in aged 18 years and older, and with an eosinophilic
phenotype. IL-5 is the most selective eosinophil cytokine known and
plays a major role in the maturation, activation and survival of
eosinophils. In asthma patients, the eosinophilic phenotype is
associated with compromised lung function, more frequent symptoms, and
increased risk of exacerbations. Reslizumab binds to human IL-5 and
prevents it from binding to the IL-5 receptor, thereby reducing
eosinophilic inflammation.
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.
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Source: Teva Pharmaceutical Industries Ltd.
Teva Pharmaceutical Industries Ltd.
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