The US Food and Drug Administration (FDA) has approved Teva's CINQAIR injection for treating asthma. The treatment is expected to become commercially available to patients, by prescription, during the second quarter of 2016.
CINQAIR (reslizumab) Injection 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, and with an eosinophilic phenotype. It is administered by intravenous (IV) infusion at a weight-based dose of 3 mg/kg once every four weeks.
“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."
Michael Hayden, President of Global R&D and Chief Scientific Officer at Teva said, “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.”
In the studies on which FDA approval was based, 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.
Rob Koremans, President and CEO of Teva Global Specialty Medicines, said, "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. We are pleased to expand our growing respiratory portfolio with CINQAIR in the US. 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.”
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.
Published by Globes [online], Israel business news - www.globes-online.com - on March 24, 2016
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