FDA Approves Teva’s Cinqair for the Treatment of Severe Asthma

FDA approved Teva Pharmaceutical’s Cinqair (reslizumab) on March 23, 2016 for use with other asthma medicines for the maintenance treatment of severe asthma in patients 18 years and older. Cinqair is approved for patients who have a history of severe asthma attacks (exacerbations) despite receiving their current asthma medicines.

Cinqair is administered once every four weeks via intravenous infusion by a health care professional in a clinical setting prepared to manage anaphylaxis. Cinqair is a humanized interleukin-5 antagonist monoclonal antibody produced by recombinant DNA technology in murine myeloma non-secreting 0 (NS0) cells. The drug reduces severe asthma attacks by reducing the levels of blood eosinophils, a type of white blood cell that contributes to the development of asthma.

The safety and efficacy of Cinqair were established in four double-blind, randomized, placebo‑controlled trials in patients with severe asthma on currently available therapies. Cinqair or a placebo was administered to patients every four weeks as an add-on asthma treatment. Compared with placebo, patients with severe asthma receiving Cinqair had fewer asthma attacks, and a longer time to the first attack. In addition, treatment with Cinqair resulted in a significant improvement in lung function, as measured by the volume of air exhaled by patients in one second.

Upon commercial availability of Cinquair, Teva said in a press announcement that it would launch Teva Support Solutions, a program that will provide support, training, and education to  patients who have been prescribed Cinquair and healthcare providers. Reslizumab has also been submitted to and is currently under review by European Medicines Agency (EMA) and Health Canada.

Source: FDA, Teva