The medication developed by Teva Pharmaceutical Industries is focused on treating asthma in adults who suffer from frequent attacks despite following their doctors’ recommendations.
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Cinqair, given by injection every four weeks, is created to reduce severe asthma attacks by reducing blood levels of eosinophils, a white blood cell that contributes to asthma, the FDA said.
The United States Food and Drug Administration (FDA) announced on Wednesday the approval of the drug for severe asthma treatment called Cinqair.
Asthma is a condition that causes airways to be inflamed.
According to the Centers for Disease Control and Prevention, more than 22 million people in the US had asthma in 2013, and more than 400,000 asthma-related hospitalizations occur each year.
The drug, which Teva Pharmaceuticals makes, needs to be administered by professional in medicine. The Agency noted that the drug can as well be used alongside with other medication for any patients. The drug is indicated for patients with a history of severe asthma attacks despite using their current asthma drugs. Its safety and efficacy were established in five double-blind, randomized, placebo-controlled trials in patients with severe asthma on now available therapies. Reslizumab or placebo was administered to patients every four weeks as an add-on asthma treatment. “Under the said approval, patients 18 years old and above may take the drug together with other asthma medicines for the maintenance and treatment of severe asthma”.
“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”, says FDA’s Center for Drug Evaluation and Research Badrul Chowdhury.
Substantial improvement was seen in lung function measured by volume of air that was exhaled in 1 second.
Talking about the clinical trials, the most common side effects that were observed included muscle pain, cancer and anaphylaxis.
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To make sure that appropriate care as well as management is provided, if the patient should suddenly have signs of an allergic reaction that could be life threatening.
