The European Commission has approved a marketing authorisation for reslizumab (Teva Pharmaceutical Industries’ Cinqaero), an injectable treatment for use in severe asthma.
The decision follows a recommendation in June 2016 by the European Medicines Agency’s Committee for Medicinal Products that marketing authorisation be granted for use as an add-on therapy in adult patients with severe eosinophilic asthma inadequately controlled despite high-dose inhaled corticosteroids plus another medicinal product. The drug was approved for use in the United States in March 2016.
Clinical trials have shown that Cinqaero is able 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 ≥ 400 cells/ÂµL) and with at least one previous asthma exacerbation in the preceding year.
Cinqaero will be available as a 10mg/ml concentrate for solution for infusion, which is administered at clinics every four weeks.
Reslizumab is a humanized interleukin-5 antagonist monoclonal antibody. It binds specifically to IL5, a key cytokine responsible for the differentiation, maturation, recruitment and activation of human eosinophils, which means that survival and activity of eosinophils are reduced.
The most common side effects are increased blood creatine phosphokinase, myalgia and anaphylactic reactions. An imbalance in malignant neoplasms was observed between placebo and treatment arms during the clinical trials.
Guy Brusselle from Ghent University Hospital, Belgium, an investigator in one of the clinical trials, says: “For patients living with severe asthma, there is a significant unmet need when it comes to treatment options, despite today’s standard of care. It is exciting and encouraging to see the approval of Cinqaero in Europe as physicians seek targeted treatment options for this specific subset of patients living with uncontrolled severe eosinophilic asthma.”