First Intravenous Anti-IL-5 Biologic Therapy for Severe Eosinophilic
Asthma Now Approved in Europe
JERUSALEM--(BUSINESS WIRE)--Aug. 18, 2016--
Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) today
announced that the European Commission has granted marketing
authorization for CINQAERO® (reslizumab) in the 28 countries
of the European Union (EU) in addition to Norway, Liechtenstein and
Iceland. CINQAERO® is a humanized interleukin-5 antagonist
monoclonal antibody for add-on therapy in adult patients with severe
eosinophilic asthma inadequately controlled despite high-dose inhaled
corticosteroids plus another medicinal product for maintenance treatment.
“For patients living with severe asthma, there is a significant unmet
need when it comes to treatment options, despite today’s standard of
care,” said Professor Guy Brusselle, Ghent University Hospital, Belgium.
“It is exciting and encouraging to see the approval of CINQAERO®
in Europe as physicians seek targeted treatment options for this
specific subset of patients living with uncontrolled severe eosinophilic
asthma. In clinical trials, CINQAERO® consistently
demonstrated the ability to improve multiple levels of asthma control,
including the reduction of exacerbations and improvement of lung
function and quality of life, making it an important treatment option
for those struggling to control their disease.”
The approval by the European Commission was based on review of efficacy
and safety data from Teva’s global development program, BREATH, in
asthma. The clinical trial program consisted of five placebo-controlled
studies. The program explored the efficacy and safety profile in a
population of 1,028 adult and adolescent severe asthma patients treated
with CINQAERO® 3 mg/kg every four weeks that were
inadequately controlled with inhaled corticosteroid (ICS)-based
therapies. Side effects included increased blood creatine phosphokinase,
myalgia and anaphylactic reactions.
“Severe asthma is a significant health issue in Europe and around the
world– and for patients living with a severe form of the condition
marked by elevated eosinophils – finding an effective treatment option
may be a challenge,” said Rob Koremans, MD, President and CEO of Teva
Global Specialty Medicines. “The approval in Europe is a significant
milestone for Teva, reinforcing the important work our respiratory
division has done, and continues to do, in developing innovative
therapies. It is our hope that the availability of this treatment may
better serve, and bring much-needed relief, to patients with severe
asthma who are still struggling with symptom control, despite standard
of care therapy.”
CINQAERO® is expected to become commercially available to
patients in Europe, by prescription, within the coming months. CINQAERO®
is currently approved and marketed in the United States and Canada as
CINQAIR® (reslizumab) Injection with pending regulatory
approvals in other global markets.
About CINQAERO® (reslizumab)
CINQAERO® is a humanized interleukin-5 (IL-5) antagonist
monoclonal antibody (IgG4 kappa). IL-5 is the most selective
eosinophil-active cytokine 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. CINQAERO®
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
targeted biologics. 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 to 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.
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result of new information, future events or otherwise.
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Source: Teva Pharmaceutical Industries Ltd.
Teva Pharmaceutical Industries Ltd.
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