FDA Approves Severe Asthma Drug Cinqair

A new drug that promises relief for severe asthma sufferers has been approved by the Food and Drug Administration to go on the market by the second quarter of this year. The FDA said Cinqair  has been extensively tested and can be used with other asthma therapies which have similar components to this drug.

Teva Pharmaceutical Industries Ltd. produces Cinqair. It is administered by intravenous infusion (IV) once a month with a dose of 3 mg/kg., according to the Tampa Bay Review. It is for patients whose asthma is not well-controlled by other medications.

Currently, more than 400,000 people are hospitalized each year with asthma related symptoms, and altogether, more than 22 million Americans live with the disease, according to a 2013 report from the Centers for Disease Control and Prevention.

“The study was based on a safety test of the Cinqair drug from the FDA, as it conducted a controlled, double-blind test. In order to test its safety and efficacy, four randomized-placebo tests were performed in those individuals showing severe asthma diagnoses and were currently in ongoing treatment,” according to researchers.

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.”

Cinqair’s approval marks an important advancement in the treatment of asthma. Trials have demonstrated significant improvement in multiple measures of asthma control.

“Health care providers and their patients with severe asthma now have another treatment option to consider when the disease is not well controlled by their current asthma therapies,” stated the director of the Division of Pulmonary, Allergy, and Rheumatology Products in the FDA’s Center for Drug Evaluation and Research Badrul Chowdhury, M. D., Ph. D.