Further Analysis of Pivotal Phase III Studies Show Reduction in
Asthma Exacerbation Rates by at least half (50% and 59% respectively)
and Significant Improvement in Lung Function in Patients Treated with
Reslizumab
JERUSALEM--(BUSINESS WIRE)--Feb. 23, 2015--
Teva Pharmaceutical Industries Ltd., (NYSE: TEVA) announced today that
The Lancet Respiratory Medicine has published data from two replicate
52-week Phase III global studies on the company’s investigational
anti-interleukin-5 (IL-5) monoclonal antibody, reslizumab. The data
showed that treatment with reslizumab, compared to placebo,
significantly reduced the annual rate of clinical asthma exacerbations
(Study 1, 50% and Study 2, 59%), significantly improved lung function,
and provided sustained improvement in multiple secondary measures of
asthma control in patients with asthma and elevated blood eosinophils
who were inadequately controlled on an inhaled corticosteroid
(ICS)-based regimen. Findings from the studies were also presented today
at the 2015 American Academy of Allergy, Asthma & Immunology (AAAAI)
Annual Meeting in a late-breaking oral session.
“Results from these Phase III studies highlight the importance of
phenotype-targeted therapies and represent a potential change in the
treatment paradigm for patients with moderate-to-severe asthma and
elevated blood eosinophil levels who are uncontrolled on an ICS-based
therapy,” said Professor Mario Castro, Washington University School of
Medicine, Division of Pulmonary and Critical Care Medicine and lead
investigator. “If approved, reslizumab could provide doctors with a new
treatment option that has the potential to both significantly reduce
patients’ asthma exacerbations and improve their current symptom control
and lung function.”
Across both trials, a total of 953 patients with asthma and elevated
blood eosinophil counts, who were uncontrolled despite receiving
medium-to-high doses of ICS with or without an additional controller,
and who had at least one asthma exacerbation in the prior year, were
randomized to receive intravenously administered reslizumab (3.0 mg/kg)
or placebo every four weeks for one year. Approximately 80% of patients
in these trials were also taking an inhaled long-acting beta-agonist.
The primary efficacy variable was the annual frequency of clinical
asthma exacerbations. Lung function, quality of life, asthma control,
and safety were also assessed.
Primary efficacy was met in both studies. Results were consistent and
demonstrated that reslizumab reduced the annual frequency of clinical
exacerbations by at least half (50% and 59% respectively), compared to
placebo. Lung function also improved by week four and was maintained
through one year in both studies. Furthermore, significant improvements
were observed in the Asthma Quality of Life, Asthma Control
Questionnaire and Asthma Symptom Utility Index scores. Common adverse
events in the reslizumab treatment group were comparable to placebo and
included worsening of asthma, nasopharyngitis, upper respiratory
infections, sinusitis, influenza and headache. Two anaphylactic
reactions were reported and resolved following medical treatment at the
study site.
“We are immensely impressed by the continued positive results seen
across the entire Phase III clinical trial program for reslizumab,” said
Dr. Michael Hayden, President of Global R&D and Chief Scientific Officer
at Teva Pharmaceutical Industries Ltd. “There is a tremendous need
within the asthma patient population for targeted treatment options that
may limit the number of annual exacerbations and aid patients in
effectively controlling their condition. If approved, we look forward to
bringing this important new therapy to market as soon as possible.”
The data published today in The Lancet Respiratory Medicine and
presented at AAAAI are part of the comprehensive Phase III clinical
trial program for reslizumab and further build upon Phase III trial data
previously presented at the European Respiratory Society (ERS)
International Congress in 2014. Regulatory submissions for reslizumab
are planned for the first half of 2015.
About Reslizumab
Reslizumab is an investigational humanized monoclonal antibody (mAb)
against interleukin-5 (IL-5). IL-5 has been shown to play a crucial role
in the maturation, and survival of eosinophils, inflammatory white blood
cells implicated in a number of allergic diseases, such as asthma.
Elevated levels of blood eosinophils are a risk factor for future asthma
exacerbations. Recent data from the Phase III clinical program
demonstrated that reslizumab significantly reduced the annual rate of
asthma exacerbations and improved lung function and asthma symptoms in
patients with moderate to severe asthma with elevated blood eosinophils
whose symptoms were inadequately controlled by medium to high doses of
inhaled corticosteroids with or without an additional controller,
compared with placebo.
About the Studies
In two duplicate, double-blind, Phase III studies, a total of 953
patients with similar baseline characteristics, and with moderate to
severe asthma and elevated blood eosinophil levels were randomized to
receive either intravenous reslizumab (3.0 mg/kg) (n=477) or placebo
(n=476) every four weeks for one year. The primary endpoint was the
annual frequency of clinical asthma exacerbations. Additional
assessments included lung function, quality of life, asthma control and
safety.
Results from these studies demonstrated that patients receiving
reslizumab achieved reductions in clinical asthma exacerbations (study 1
RR 0.50 [95%CI 0.37, 0.67], study 2 RR 0.41 [95%CI 0.28, 0.59], both
P<0.0001) versus placebo. Lung function improved by the first assessment
at week four, and was maintained for one year in both studies (change in
FEV1 over 52 weeks was 0.126 L, P<0.0001 and 0.090 L,
P=0.006). Significant improvements from baseline over 52 weeks were
observed in Asthma Quality of Life Questionnaire scores (0.302, P=0.0004
and 0.234, P=0.0052), Asthma Control Questionnaire (-0.255, P=0.0002 and
-0.242, P=0.0003) and Asthma Symptom Utility Index (+0.061 [P<0.0001];
+0.036 [P=0.0011]). Common adverse events in the reslizumab treatment
group were similar to placebo; two anaphylactic reactions in the
reslizumab arm were reported that resolved with treatment at the study
site. Overall, reslizumab significantly reduced the annual rate of
clinical exacerbations and resulted in sustained improvement in
secondary measures of asthma control compared with placebo.
About Asthma
Asthma is a chronic (long-term) disease usually characterized by airway
inflammation and narrowing of the airways, which can vary over time.
Asthma may cause recurring periods of wheezing (a whistling sound when
you breathe), chest tightness, shortness of breath and coughing that
often occurs at night or early in the morning. Without appropriate
treatment, asthma symptoms may become more severe and result in an
asthma attack, which can lead to hospitalization and even death.
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 1,000 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 2014 amounted to $20.3
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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