FDA Approves Severe Asthma Maintenance Treatment

Patients with severe asthma will now have a new treatment option: reslizumab (Cinqair).

The FDA today approved Teva's Cinqair to be used with other asthma medications for the maintenance treatment of severe asthma in patients aged 18 years or older. Cinqair may also be used in patients who have a history of severe asthma exacerbations, despite their current asthma medication.

The product is administered once every 4 weeks via intravenous infusion by a health care professional in a clinical setting that is set up to handle anaphylaxis.

The product was tested in 4 double-blind, randomized, placebo-controlled trials involving patients with severe asthma who received either Cinqair or placebo every 4 weeks as an add-on therapy.

Patients who received Cinqair had fewer asthma attacks and a longer time period before the first attack. Those who received the intervention treatment also experienced significant improvement in lung function.

In these trials, Cinqair’s most common adverse events were anaphylaxis, cancer, and muscle pain.

Cinqair, a humanized interleukin-5 antagonist monoclonal antibody, works by reducing the levels of blood eosinophils, which helps to limit severe asthma attacks.

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

More than 22 million individuals in the country have asthma, and there are more than 400,000 asthma-related hospitalizations each year, according to the US Centers for Disease Control and Prevention.