FDA approves Cinqair (reslizumab) to treat eosinophilic asthma- Teva

Teva Pharmaceutical Industries Ltd. announced that the FDA has approved Cinquair (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. Cinquair 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.

Three studies constituted the Phase III program in patients with asthma and elevated blood eosinophils. They demonstrated that treatment with Cinquair 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 Cinquair 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 (Cinquair 0.6% and placebo 0.3%). The observed malignancies were diverse in nature and were diagnosed within less than six months of exposure to Cinquair.

Reslizumab has been submitted to and is currently under review by European Medicines Agency (EMA) and Health Canada.

Comment:The FDA Cinqair approval does not extend to adolescents due to a lack of data, in contrast to the FDA approval for Nucala (mepolizumab) from GSK. Cinqair is administered by intravenous infusion over 20-50 minutes four times a week and Nucala is provided four times a week, subcutaneously.