FDA approves Teva’s CINQAIR Injection for asthma treatment

Teva Pharmaceutical Industries Ltd. announced last week that the U.S. Food and Drug Administration (FDA) has approved its interleukin 5 antagonist monoclonal antibody (lgG4 kappa), CINQAIR (reslizumab) Injection.

CINQAIR was developed to treat patients ages 18 years and up who suffer from severe asthma who also have an eosinophilic phenotype. The medication is administered once every four weeks by an intravenous (IV) infusion through dosages of 3 mg/kg that is based on the patient’s weight. CINQAIR is expected to be available to patients commercially with a prescription as soon as the second quarter of this year.

CINQAIR was approved by the FDA based on the review of data that proved the medication’s safety and effectiveness. The data was produced by Teva’s worldwide asthma developmental program. Clinical trials were conducted as part of the program and included five placebo-controlled studies. These studies confirmed the safety and effectiveness of CINQAIR based on a population of 1,028 patients, both adult and adolescent, who have asthma.

The Phase III program consisted of three studies in patients with asthma who also had elevated eosinophils. Treatment with CINQAIR saw the reduction of asthma exacerbations in 59 percent and an improvement of lung function, symptoms and quality of life.