WEDNESDAY, March 23, 2016 -- Cinqair (reslizumab) has been approved by the U.S. Food and Drug Administration to treat severe asthma among adults 18 and older.
The drug is to be used in combination with other medications, the agency noted.
In a Wednesday news release, the agency said that more than 22 million people in the United States have asthma, which leads to more than 400,000 hospitalizations annually.
Cinqair, given by injection every four weeks, is designed to reduce severe asthma attacks by reducing 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. Users of Cinqair, a lab-developed "interleukin-5 antagonist monoclonal antibody," also had improved lung function compared to a placebo.
The FDA warned, however, that Cinqair could cause severe allergic-like reactions that could be life threatening. The most common clinical side effects also included cancer and muscle pain.
The drug is produced by Teva Pharmaceuticals, based in Frazer, Penn.More information
Learn more about this approval from the FDA.
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