FDA approves Cinqair for severe asthma

The FDA approved Cinqair for use with other asthma medicines for the maintenance treatment of severe asthma in patients aged 18 years and older, according to a press release.

“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,” Badrul Chowdhury, MD, PhD, director of the Division of Pulmonary, Allergy, and Rheumatology Products in the FDA’s Center for Drug Evaluation and Research, said in the release.

Cinqair (reslizumab, Teva), a humanized interleukin-5 antagonist monoclonal antibody, is administered by a health care professional through intravenous infusion once every four weeks. Cinqair is manufactured by recombinant DNA technology in murine myeloma non-secreting 0 (NS0) cells.

By lowering the levels of blood eosinophils, a type of white blood cell that impacts the development of asthma, Cinqair decreases severe asthma attacks.

The FDA approval stems from the efficacy and safety data of four double-blind, randomized, placebo‑controlled trials that included patients with severe asthma on currently available therapies, according to the release.

Data indicated that patients with severe asthma who were administered Cinqair exhibited fewer asthma attacks and experienced longer time to the first attack, compared to the placebo. Patients also saw substantial improvement in lung function measured by the volume of air exhaled in one second.

Treatment with Cinqair, however, can cause potential life-threatening side effects such as allergic (hypersensitivity) reactions. In clinical trials, the most common reported adverse events observed were anaphylaxis, cancer and muscle pain.