Teva announces FDA approval for asthma injection, Cinqair
pharmafile | March 24, 2016 | News story | Research and Development, Sales and Marketing | FDA, Teva, approval, asthma, cinqair
The US Food and Drug Administration has approved Cinqair (reslizumab), an injection for patients with severe asthma developed by Teva Pharmaceuticals (NYSE/TASE: TEVA).
Cinqair 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 (a distinct phenotype within asthma). Following this approval, it is set to become commercially available, via prescription, during Q2 2016.
Phase III studies indicated that 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.
Lead investigator of the study, Professor Mario Castro, comments: “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. As a practising physician, I look forward to the opportunity to provide my patients, who have severe uncontrolled asthma and fit the profile for Cinqair, with an option that has the potential to help them achieve control of their disease.”
Michael Hayden, president of global R&D and chief scientific officer at Teva, says: “Teva’s speciality medicines pipeline is centred on developing therapies to address the unmet needs of patients, healthcare providers, caregivers, and payers in our key therapeutic areas of focus. 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.”
Upon the commercial availability of Cinqair, the Israel-based company will launch Teva Support Solutions, a comprehensive program that will provide personalised support, training and education to healthcare providers and patients who have been described the treatment.
This FDA approval is the first of its kind anywhere in the world. Teva have also made submissions to the European Medicines Agency (EMA) and Health Canada. Those submissions are currently under review.
Sean Murray
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