New Phase III data presented at European Respiratory Society Congress (ERS) builds on recent exacerbation reduction data, creating a special efficacy profile for reslizumab
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Reslizumab shown to significantly improve lung function and asthma control
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Findings support reslizumab benefits specifically for moderate to severe asthma patients with elevated level of blood eosinophils
JERUSALEM, Israel I September 8, 2014 I Teva Pharmaceutical Industries Ltd. (NYSE:TEVA) today announced positive new data from Phase III studies of the company’s anti-IL5 monoclonal antibody, reslizumab, in patients with uncontrolled moderate to severe asthma with elevated eosinophils, treated with standard of care therapies. The data demonstrated that reslizumab treatment resulted in significant improvement in lung function and asthma control measures and showed a safety profile comparable to placebo.
Reslizumab treatment (3.0 mg/kg and 0.3 mg/kg IV injection every four weeks) resulted in significant improvements in lung function versus placebo when administered to patients, with moderate to severe asthma with elevated eosinophils. Improvement was measured by overall change in Forced Expiratory Volume in 1 second (FEV1), a standard measure of the degree of airway obstruction in asthma. Improvements were noted as early as four weeks after initial dose administration and were maintained at the end of the 16 week treatment period. Furthermore, reslizumab produced significant improvements in patient reported asthma control, assessed by using the Asthma Control Questionnaire (ACQ), which includes questions on symptoms, activity limitation, and the use of non-steroidal rescue medication. Improvements in FEV1 and ACQ for the 0.3 mg/kg dose were numerically smaller than for the 3 mg/kgdose.
The majority of reported adverse events (AEs) were mild to moderate and comparable across the treatment groups. The most common AEs in any treatment group were asthma, headache, nasopharyngitis, and upper respiratory tract infection.
“Uncontrolled asthma with eosinophilia is in desperate need of novel targeted therapies. The key aspects to the success of a treatment for these patients is the confidence and reduced impact on quality of life that comes from reduced exacerbations and the sense of normality that comes with better disease control. Reslizumab fulfills an important unmet need and has the potential to deliver on both counts,” said Dr. Leif Bjermer, principal investigator of the study and professor of respiratory medicine and allergology at Skane University Hospital in Lund, Sweden.
Results from a second study, utilizing only the 3 mg/kg dose of reslizumab, in an asthma population that was not selected for elevated blood eosinophils, demonstrated minimal improvements in asthma control, and provides support for the eosinophil threshold of ≥400/µL set for the reslizumab phase III program.
“Teva has conducted an extensive and robust phase III clinical trial program that has clearly demonstrated the potential utility of reslizumab for patients who face a very challenging asthmatic condition. Reduced exacerbation, improved lung function and better asthma control positions reslizumab as a potential new targeted therapy for patients with uncontrolled asthma associated with elevated eosinophils,” said Dr. Michael Hayden, President of Global R&D and Chief Scientific Officer at Teva Pharmaceutical Industries Ltd.”
Teva-Sponsored Data Highlights Include:
A randomized phase III study of the efficacy and safety of reslizumab in subjects with asthma with elevated eosinophils (Poster Presentation on Sunday, Sept 7, 2014. 8:30 – 10:30am. Session 57) Leif Bjermer, Catherine Lemiere, Jorge Maspero, Monika Ciesielska, Christopher O’Brien, James Zangrilli.
A randomized phase III study of reslizumab efficacy in relation to blood eosinophil levels in patients with moderate to severe asthma (Oral Presentation: Wednesday, Sept 10, 2014. 10:15am. Session 488) Jonathan Corren, Steven Weinstein, Lindsay Janka, Christopher O’Brien, James Zangrilli
The full abstracts can be found at: https://www.ersnetsecure.org/public/prg_congres.entree?ww_i_congres=149
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, growth and chemotaxis (movement) of eosinophils, inflammatory white blood cells implicated in a number of allergic diseases. Recently announced results from two pivotal Phase III studies demonstrated that reslizumab treatment (3.0 mg/kg IV injection every four weeks) resulted in statistically significant reductions in the frequency of clinical asthma exarcebations compared to placebo (50% and 60% respectively, P<0.0001 for both) with an adverse event profile comparable to placebo.
About the Studies
Study NCT01270464 was a 16-week, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy and safety of reslizumab (0.3 or 3.0 mg/kg) as treatment for patients (12-75 years of age, n=311) with eosinophilic asthma
The primary objective was is to determine whether reslizumab administered once every 4 weeks for a total of 4 doses, is more effective than placebo in improving lung function in patients with eosinophilic asthma.
Study NCT01508936 was a 16-week, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of reslizumab (3.0 mg/kg IV injection every four weeks) treatment in patients (18-65 years of age, n= 492) with moderate to severe asthma.
The primary objective of the study was to assess reslizumab effect on FEV1 in relation to baseline blood eosinophils in subjects with moderate to severe asthma.
About Asthma
Asthma is a common, chronic inflammatory condition that affects approximately 12% of adults and 10% of children and adolescents; it is estimated that 300 million people worldwide suffer from this condition. Patients with inadequately controlled severe persistent asthma are at risk of exacerbations, hospitalization and death, and often have impaired quality of life.
About Teva
Teva Pharmaceutical Industries Ltd. (NYSE:TEVA) is a leading global pharmaceutical company, committed to increasing access to high-quality healthcare by developing, producing and marketing affordable generic drugs as well as innovative and specialty pharmaceuticals and active pharmaceutical ingredients. Headquartered in Israel, Teva is the world’s leading generic drug maker, with a global product portfolio of more than 1,000 molecules and a direct presence in approximately 60 countries. Teva’s Specialty Medicines businesses focus on CNS, respiratory, oncology, pain, and women’s health therapeutic areas as well as biologics. Teva currently employs approximately 45,000 people around the world and reached $20.3 billion in net revenues in 2013.
SOURCE: Teva Pharmaceutical Industries
Post Views: 32
New Phase III data presented at European Respiratory Society Congress (ERS) builds on recent exacerbation reduction data, creating a special efficacy profile for reslizumab
-
Reslizumab shown to significantly improve lung function and asthma control
-
Findings support reslizumab benefits specifically for moderate to severe asthma patients with elevated level of blood eosinophils
JERUSALEM, Israel I September 8, 2014 I Teva Pharmaceutical Industries Ltd. (NYSE:TEVA) today announced positive new data from Phase III studies of the company’s anti-IL5 monoclonal antibody, reslizumab, in patients with uncontrolled moderate to severe asthma with elevated eosinophils, treated with standard of care therapies. The data demonstrated that reslizumab treatment resulted in significant improvement in lung function and asthma control measures and showed a safety profile comparable to placebo.
Reslizumab treatment (3.0 mg/kg and 0.3 mg/kg IV injection every four weeks) resulted in significant improvements in lung function versus placebo when administered to patients, with moderate to severe asthma with elevated eosinophils. Improvement was measured by overall change in Forced Expiratory Volume in 1 second (FEV1), a standard measure of the degree of airway obstruction in asthma. Improvements were noted as early as four weeks after initial dose administration and were maintained at the end of the 16 week treatment period. Furthermore, reslizumab produced significant improvements in patient reported asthma control, assessed by using the Asthma Control Questionnaire (ACQ), which includes questions on symptoms, activity limitation, and the use of non-steroidal rescue medication. Improvements in FEV1 and ACQ for the 0.3 mg/kg dose were numerically smaller than for the 3 mg/kgdose.
The majority of reported adverse events (AEs) were mild to moderate and comparable across the treatment groups. The most common AEs in any treatment group were asthma, headache, nasopharyngitis, and upper respiratory tract infection.
“Uncontrolled asthma with eosinophilia is in desperate need of novel targeted therapies. The key aspects to the success of a treatment for these patients is the confidence and reduced impact on quality of life that comes from reduced exacerbations and the sense of normality that comes with better disease control. Reslizumab fulfills an important unmet need and has the potential to deliver on both counts,” said Dr. Leif Bjermer, principal investigator of the study and professor of respiratory medicine and allergology at Skane University Hospital in Lund, Sweden.
Results from a second study, utilizing only the 3 mg/kg dose of reslizumab, in an asthma population that was not selected for elevated blood eosinophils, demonstrated minimal improvements in asthma control, and provides support for the eosinophil threshold of ≥400/µL set for the reslizumab phase III program.
“Teva has conducted an extensive and robust phase III clinical trial program that has clearly demonstrated the potential utility of reslizumab for patients who face a very challenging asthmatic condition. Reduced exacerbation, improved lung function and better asthma control positions reslizumab as a potential new targeted therapy for patients with uncontrolled asthma associated with elevated eosinophils,” said Dr. Michael Hayden, President of Global R&D and Chief Scientific Officer at Teva Pharmaceutical Industries Ltd.”
Teva-Sponsored Data Highlights Include:
A randomized phase III study of the efficacy and safety of reslizumab in subjects with asthma with elevated eosinophils (Poster Presentation on Sunday, Sept 7, 2014. 8:30 – 10:30am. Session 57) Leif Bjermer, Catherine Lemiere, Jorge Maspero, Monika Ciesielska, Christopher O’Brien, James Zangrilli.
A randomized phase III study of reslizumab efficacy in relation to blood eosinophil levels in patients with moderate to severe asthma (Oral Presentation: Wednesday, Sept 10, 2014. 10:15am. Session 488) Jonathan Corren, Steven Weinstein, Lindsay Janka, Christopher O’Brien, James Zangrilli
The full abstracts can be found at: https://www.ersnetsecure.org/public/prg_congres.entree?ww_i_congres=149
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, growth and chemotaxis (movement) of eosinophils, inflammatory white blood cells implicated in a number of allergic diseases. Recently announced results from two pivotal Phase III studies demonstrated that reslizumab treatment (3.0 mg/kg IV injection every four weeks) resulted in statistically significant reductions in the frequency of clinical asthma exarcebations compared to placebo (50% and 60% respectively, P<0.0001 for both) with an adverse event profile comparable to placebo.
About the Studies
Study NCT01270464 was a 16-week, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy and safety of reslizumab (0.3 or 3.0 mg/kg) as treatment for patients (12-75 years of age, n=311) with eosinophilic asthma
The primary objective was is to determine whether reslizumab administered once every 4 weeks for a total of 4 doses, is more effective than placebo in improving lung function in patients with eosinophilic asthma.
Study NCT01508936 was a 16-week, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of reslizumab (3.0 mg/kg IV injection every four weeks) treatment in patients (18-65 years of age, n= 492) with moderate to severe asthma.
The primary objective of the study was to assess reslizumab effect on FEV1 in relation to baseline blood eosinophils in subjects with moderate to severe asthma.
About Asthma
Asthma is a common, chronic inflammatory condition that affects approximately 12% of adults and 10% of children and adolescents; it is estimated that 300 million people worldwide suffer from this condition. Patients with inadequately controlled severe persistent asthma are at risk of exacerbations, hospitalization and death, and often have impaired quality of life.
About Teva
Teva Pharmaceutical Industries Ltd. (NYSE:TEVA) is a leading global pharmaceutical company, committed to increasing access to high-quality healthcare by developing, producing and marketing affordable generic drugs as well as innovative and specialty pharmaceuticals and active pharmaceutical ingredients. Headquartered in Israel, Teva is the world’s leading generic drug maker, with a global product portfolio of more than 1,000 molecules and a direct presence in approximately 60 countries. Teva’s Specialty Medicines businesses focus on CNS, respiratory, oncology, pain, and women’s health therapeutic areas as well as biologics. Teva currently employs approximately 45,000 people around the world and reached $20.3 billion in net revenues in 2013.
SOURCE: Teva Pharmaceutical Industries
Post Views: 32
