EU grants marketing authorisation for Teva’s asthma drug Cinqaero
pharmafile | August 19, 2016 | News story | Medical Communications, Sales and Marketing | EU, Teva, approval, asthma, cinqaero, eosinophilic
The European Commission has granted marketing authorisation for Teva’s Cinqaero (reslizumab), as an odd-on therapy in adult patients with severe eosinophilic asthma inadequately controlled despite high-dose inhaled corticosteroids plus another medicinal product for maintenance treatment.
Cinqaero is a humanised interleukin-5 (IL-5) antagonist monoclonal antibody. IL-5 plays a major role in the maturation, activation and survival of eosinophils, which is associated with compromised lung function and increased risk of exacerbations.
The EU’s approval is based on data from Teva’s late-stage BREATH trials. These five trials explored the efficacy and safety profile of Cinqaero in 1,028 adult and adolescent severe asthma patients whose condition was inadequately uncontrolled with inhaled corticosteroid-based therapies.
Professor Guy Brusselle, from Ghent University Hospital, 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.
“In clinical trials, Cinqaero consistently demonstrated the ability to improve multiple levels of asthma control, including the reduction of exacerbations and improvement of lung function and quality of life, making it an important treatment option for those struggling to control their disease.”
Sean Murray
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