EMA committee recommends approval of Teva’s Cinqaero asthma drug

The US Food and Drug Administration approved the product, branded as Cinqair in the US, in March.

Cinqaero is a humanized monoclonal antibody that binds to interleukin 5 (IL-5) as add-on therapy in adult patients with severe inadequately controlled eosinophilic asthma despite high-dose inhaled corticosteroids and another medicinal product for maintenance treatment.

Prior to its decision, the CHMP reviewed a marketing authorization application that included efficacy and safety data from the company’s worldwide development program in asthma.

The program included five placebo-controlled trials which evaluated the efficacy and/or safety profile in 1,028 adult and adolescent asthma patients treated with reslizumab 3 mg/kg that were inadequately controlled with inhaled corticosteroid (ICS)-based therapies.

Three of those studies included the Phase III program in patients with asthma and elevated blood eosinophils of over 400 cells/mcL, where reslizumab was administered for about 52 weeks.

Teva said treatment with reslizumab reduced the annual rate of asthma exacerbations in the two 52-week trials by 50 and 59 percent, respectively.

Additionally, reslizumab was related with significant improvement in lung function, patient-reported asthma control and asthma-related quality of life measures.

Teva Global Specialty Medicines president and CEO Rob Koremans said: "In clinical trials, reslizumab was effective in reducing asthma exacerbations, improving lung function and improving asthma-related quality of life measures.

"It is our hope that we can expand the availability of reslizumab globally and soon bring this important treatment option to a specific group of severe eosinophilic asthma patients in Europe who struggle to control their symptoms despite today’s standard of care."