The U.S. Food and Drug Administration has approved the use of reslizumab with other asthma medication for maintenance treatment in adult patients with a history of severe asthma attacks.

The drug is a humanized monoclonal antibody of the IgG4/K isotype, and reduces blood levels of eosinophils. The intravenously infused biologic must be administered in a clinical setting by a health professional who is prepared to manage anaphylaxis, according to a written statement from the FDA.

In December, the FDA’s Pulmonary-Allergy Drug Advisory Committee had recommended approval of the drug for use in 18- to 75-year-olds with inadequately controlled eosinophilic asthma, based on the results of phase III double-blind randomized, placebo-controlled trials in which the drug was administered every 4 weeks as an add-on asthma treatment. As compared with patients who received a placebo, patients who received the drug had fewer asthma attacks, had a later-onset first attack, and experienced a significant improvement in lung function based on measures of forced expiratory volume in 1 second.

The most common side effects of taking reslizumab experienced by patients in clinical trials included anaphylaxis, cancer, and muscle pain.

Teva Pharmaceuticals is marketing the drug as Cinqair.


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