JERUSALEM, Israel I December 10, 2015 I Teva Pharmaceutical Industries Ltd., (NYSE:TEVA) announced today that the U.S. Food and Drug Administration’s (FDA) Pulmonary-Allergy Drugs Advisory Committee recommended approval of reslizumab, a humanized anti-interleukin-5 (IL-5) IgG4K monoclonal antibody (mAb), in adult patients aged 18 years and older. Reslizumab is a targeted biologic therapy for the treatment of inadequately controlled asthma in patients with elevated blood eosinophils, despite an inhaled corticosteroid (ICS)-based treatment regimen.
“Patient stratification based on eosinophil levels has been an important advancement in the treatment of asthma,” said Michael Hayden, M.D., Ph.D., President of Global R&D and Chief Scientific Officer at Teva Pharmaceutical Industries Ltd. “We are very encouraged by the outcome of today’s FDA Advisory Committee meeting, which brings us one step closer to potentially providing a new, targeted treatment option for a specific group of patients with inadequately controlled asthma and evidence of ongoing eosinophilic inflammation. This group of patients often experiences persistent symptoms despite standard-of-care treatment, demonstrating a need for more targeted treatment options based on patient phenotype.”
The Advisory Committee’s recommendation will be considered by the FDA in its review of the Biologics License Application (BLA) for reslizumab. The FDA is not bound by the Committee’s recommendation, but takes its advice into consideration when reviewing investigational medicines. The reslizumab BLA was accepted for standard review by the FDA and Regulatory Action is expected in March 2016. Additional regulatory filings for reslizumab have been completed in the EU and Canada.
About Reslizumab
Reslizumab is an investigational humanized interleukin-5 (IL-5) antagonist IgG4K monoclonal antibody (mAb), for the treatment of inadequately controlled asthma in adult and adolescent patients with elevated blood eosinophils, despite an inhaled corticosteroid (ICS)-based regimen. IL-5 is the most selective eosinophil cytokine known and plays a major role in the maturation, activation and survival of eosinophils, which are the predominant type of white blood cell underlying chronic airway inflammation in the eosinophilic phenotype of asthma. In asthma patients, elevated blood eosinophils ≥400 cells/mcL are associated with compromised lung function, persistent symptoms, and increased risk of exacerbations. Reslizumab is thought to act by binding to and neutralizing human IL-5 to reduce eosinophilic inflammation. Reslizumab has been submitted for and is currently under review by the U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA) and Health Canada.
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 inadequately controlled 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 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.
SOURCE: Teva Pharmaceutical Industries
Post Views: 43
JERUSALEM, Israel I December 10, 2015 I Teva Pharmaceutical Industries Ltd., (NYSE:TEVA) announced today that the U.S. Food and Drug Administration’s (FDA) Pulmonary-Allergy Drugs Advisory Committee recommended approval of reslizumab, a humanized anti-interleukin-5 (IL-5) IgG4K monoclonal antibody (mAb), in adult patients aged 18 years and older. Reslizumab is a targeted biologic therapy for the treatment of inadequately controlled asthma in patients with elevated blood eosinophils, despite an inhaled corticosteroid (ICS)-based treatment regimen.
“Patient stratification based on eosinophil levels has been an important advancement in the treatment of asthma,” said Michael Hayden, M.D., Ph.D., President of Global R&D and Chief Scientific Officer at Teva Pharmaceutical Industries Ltd. “We are very encouraged by the outcome of today’s FDA Advisory Committee meeting, which brings us one step closer to potentially providing a new, targeted treatment option for a specific group of patients with inadequately controlled asthma and evidence of ongoing eosinophilic inflammation. This group of patients often experiences persistent symptoms despite standard-of-care treatment, demonstrating a need for more targeted treatment options based on patient phenotype.”
The Advisory Committee’s recommendation will be considered by the FDA in its review of the Biologics License Application (BLA) for reslizumab. The FDA is not bound by the Committee’s recommendation, but takes its advice into consideration when reviewing investigational medicines. The reslizumab BLA was accepted for standard review by the FDA and Regulatory Action is expected in March 2016. Additional regulatory filings for reslizumab have been completed in the EU and Canada.
About Reslizumab
Reslizumab is an investigational humanized interleukin-5 (IL-5) antagonist IgG4K monoclonal antibody (mAb), for the treatment of inadequately controlled asthma in adult and adolescent patients with elevated blood eosinophils, despite an inhaled corticosteroid (ICS)-based regimen. IL-5 is the most selective eosinophil cytokine known and plays a major role in the maturation, activation and survival of eosinophils, which are the predominant type of white blood cell underlying chronic airway inflammation in the eosinophilic phenotype of asthma. In asthma patients, elevated blood eosinophils ≥400 cells/mcL are associated with compromised lung function, persistent symptoms, and increased risk of exacerbations. Reslizumab is thought to act by binding to and neutralizing human IL-5 to reduce eosinophilic inflammation. Reslizumab has been submitted for and is currently under review by the U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA) and Health Canada.
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 inadequately controlled 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 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.
SOURCE: Teva Pharmaceutical Industries
Post Views: 43
