Teva Pharmaceutical Industries Ltd. announced that the U.S. Food and Drug Administration (FDA) has approved CINQAIR® (reslizumab) Injection, 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.
CINQAIR® is administered by intravenous (IV) infusion at a weight-based dose of 3 mg/kg once every four weeks. The treatment is expected to become commercially available to patients, by prescription, during the second quarter of 2016.
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®. IANS
