Cinqair (reslizumab) approved for treatment of severe asthma
Mar 24 2016
The U.S. Food and Drug Administration has approved reslizumab, which will be sold under the name Cinqair, as a treatment for severe asthma in patients aged 18 and above.
The drug, made by Teva Pharmaceuticals, should be administered by a medical professional in a clinical setting. Records from the Centers for Disease Control and Prevention (CDC) show that as of 2013, over 22 million Americas suffer from the disease, and over 400,000 asthma-related hospitalizations occur each year.
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.
Such move allows asthmatic patients who have a history of severe attacks to have another supportive drug despite taking other existing therapies. Cinqair is manufactured by recombinant DNA technology in murine myeloma non-secreting 0 (NS0) cells.
The patients received either Cinqair or placebo every four weeks as supplementary asthma treatment.
Compared with placebo, patients with severe asthma receiving Cinqair had fewer asthma attacks, and a longer time to the first attack.
Nucala was approved by the FDA in November and, like Cinqair, is an antibody that reduces levels of eosinophils, a type of white blood cell that contributes to the development of asthma.
The FDA warned, however, that Cinqair could cause severe allergic-like reactions that could kill the patient. There are some side effects, however, that may be life-threatening, including cancer and muscle pain.
Upon commercial availability of CINQAIRÂ®, Teva will launch Teva Support Solutions, a comprehensive program that will provide personalized support, training and education to healthcare providers and patients who have been prescribed CINQAIR.