Reslizumab (Cinqair) Approved to Treat Severe Asthma


March 23, 2016

The US Food and Drug Administration (FDA) today approved a maintenance drug for adults with severe asthma who keep having attacks despite treatment with other medications.

The new drug, reslizumab (Cinqair, Teva Pharmaceuticals), is a monoclonal antibody. It is indicated as an adjunct to other asthma drugs for patients 18 years of age and older whose condition is linked to elevated eosinophils, a type of white blood cell that can cause airway inflammation.

Reslizumab reduces severe asthma by lowering blood levels of eosinophils. The FDA estimates that roughly 1 in 20 patients with asthma have a severe and often uncontrolled version of the illness with an eosinophilic phenotype, despite maximum therapy.

Patients receive reslizumab every 4 weeks by intravenous infusion in a clinical setting prepared to manage anaphylaxis.

An FDA advisory panel in December 2015 voted 11 to 3 to recommend approval of reslizumab for adults with severe asthma based on safety and efficacy data from clinical trials. However, the panel voted unanimously against approving the drug for children, largely because not enough children were studied.

Four double-blind, randomized, placebo-control trials clinched final approval of reslizumab, the FDA said in a news release. They involved patients with severe asthma receiving currently available therapies who received reslizumab or a placebo every 4 weeks as an add-on treatment. Those receiving reslizumab had fewer asthma attacks and a longer time to the first attack compared with patients receiving the placebo. Also, patients treated with reslizumab could exhale a significantly greater volume of air in 1 second than before.

The most common adverse events that emerged in the clinical trials were muscle pain, cancer, and anaphylaxis, which the FDA said could be life-threatening.

Teva Pharmaceuticals said in a news release that 0.6% of patients receiving 3 mg/kg reslizumab had at least one malignant neoplasm reported compared with 0.3% patients in the placebo group.

More information on today's FDA announcement is available on the agency's website.


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