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FDA Approves Reslizumab (Cinqair) to Treat Severe Asthma

Monoclonal antibody is used for maintenance treatment in adults

The FDA has given the green light to reslizumab (Cinqair, Teva Pharmaceuticals) for use with other asthma medications for the maintenance treatment of severe asthma in patients 18 years of age and older. Reslizumab is approved for patients who have a history of severe asthma attacks (exacerbations) despite receiving their current asthma medications.

According to the Centers for Disease Control and Prevention, more than 22 million people in the U.S. had asthma in 2013, and more than 400,000 asthma-related hospitalizations occur each year.

Reslizumab is administered once every four weeks via intravenous infusion by a health care professional in a clinical setting prepared to manage anaphylaxis. Reslizumab is a humanized interleukin-5 antagonist monoclonal antibody produced by recombinant DNA technology in murine myeloma nonsecreting 0 (NS0) cells. The treatment reduces severe asthma attacks by reducing the levels of blood eosinophils, which contribute to the development of asthma.

The safety and efficacy of reslizumab were established in four double-blind, randomized, placebo-controlled studies in patients with severe asthma receiving currently available therapies. Reslizumab or placebo was administered to patients every four weeks as an add-on asthma treatment. Compared with placebo, patients with severe asthma receiving reslizumab had fewer asthma attacks and longer periods to the first attack. In addition, treatment with reslizumab resulted in a significant improvement in lung function, as measured by the forced expiratory volume in one second (FEV1).

Reslizumab can cause serious adverse events, including allergic (hypersensitivity) reactions. These reactions can be life-threatening. The most common adverse events in clinical trials of reslizumab included anaphylaxis, cancer, and myalgia.

Source: FDA; March 23, 2016.

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