FDA approves Teva's Cinqair (reslizumab) Injection

New biologic for add-on maintenance treatment in adults with severe asthma and an eosinophilic phenotype.

Cinqair is administered by intravenous (IV) infusion at a weight-based dose of 3 mg/kg once every 4 weeks. The treatment is expected to become commercially available to patients, by prescription, during the second quarter of 2016.

“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. As a practicing 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.”

“Teva’s specialty medicines pipeline is centered on developing therapies to address the unmet needs of patients, healthcare providers, caregivers, and payers in our key therapeutic areas of focus,” said Michael Hayden, President of Global R&D and Chief Scientific Officer at Teva. “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.”

The FDA approval of Cinqair was based on review of efficacy and safety data from Teva’s global development program in asthma. The clinical trial program consisted of five placebo-controlled studies which demonstrated the efficacy and safety profile in a population of 1,028 adult and adolescent asthma patients treated with Cinqair 3 mg/kg that were inadequately controlled with inhaled corticosteroid (ICS)-based therapies. Three of these studies constituted the Phase III program in patients with asthma and elevated blood eosinophils. They demonstrated 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. The most common adverse reaction (incidence greater than or equal to two percent) in patients treated with Cinqair was oropharyngeal pain. Anaphylaxis was reported at a rate of 0.3% in the placebo-controlled studies (n=1028). An imbalance in malignancy was observed in the Phase III trials (Cinqair 0.6% and placebo 0.3%). The observed malignancies were diverse in nature and were diagnosed within less than six months of exposure to Cinqair.

“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,” said Rob Koremans, President and CEO of Teva Global Specialty Medicines. “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.”

Upon commercial availability of Cinqair, Teva will launch Teva Support Solutions, a comprehensive program that will provide personalized support, training and education to healthcare providers and patients who have been prescribed Cinqair.

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.