FDA Approves Teva's Asthma Injection to Treat Severe Asthma

Cinqair (reslizumab) has been approved by the U.S.Food and Drug Administration to treat serious asthma among adults 18 and older.

Asthma is a chronic disease that causes inflammation in the airways of the lungs.

"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," said Badrul Chowdhury, M.D., Ph.D., director of the Division of Pulmonary, Allergy, and Rheumatology Products in the FDA's Center for Drug Evaluation and Research.

Cinqair is approved for patients who have a history of severe asthma attacks (exacerbations) despite getting their asthma medicines.

The drug is to be used in combination with other medications, the agency noted.

More than 22 million people in the United States suffer from asthma, which makes more than 400,000 hospitalizations every year.

Cinqair, taken by injection every four weeks, is designed to decrease severe asthma attacks by lowering blood levels of eosinophils, a white blood cell that contributes to asthma, the FDA said.

In clinical studies involving an unspecified number of severe asthma sufferers, people who took Cinqair had fewer severe attacks than those who took a placebo, and a longer time to the first attack, the agency said.

Cinqair is a humanized interleukin-5 antagonist monoclonal antibody produced by recombinant DNA technology in murine myeloma non-secreting 0 (NS0) cells.

The FDA warned, however, that Cinqair could cause severe allergic-like reactions that could kill the patient. The most common side effects are cancer,anaphylaxis and muscle pain.

Cinqair is produced by Teva Pharmaceuticals in Frazer, Pennsylvania.