EU CHMP recommends approval of Cinqaero (reslizumab) as add-on treatment in adult patients with severe eosinophilic asthma- Teva
The EU Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Cinqaero (reslizumab), from Teva, intended as add-on treatment in adult patients with severe eosinophilic asthma.
Studies show that the benefits with Cinqaero are its ability to reduce the exacerbation rate and improve lung function and asthma-related quality of life in patients with severe eosinophilic asthma (with blood eosinophil count of at least 400 cells/?L) and with at least one previous asthma exacerbation in the preceding year. The most common side effects are increased blood creatine phosphokinase, myalgia and anaphylactic reactions. An imbalance in malignant neoplasms was observed during the clinical trials between placebo and treatment arms.
Comment:The FDA Cinqair approval earlier this year does not extend to adolescents due to a lack of data, in contrast to the FDA approval for Nucala (mepolizumab) from GSK. Cinqair is administered by intravenous infusion over 20-50 minutes four times a week and Nucala is provided four times a week, subcutaneously.
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