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June 26, 2016

EMA CHMP issues positive opinion for Teva’s Cinqaero

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending marketing authorisation for Israeli-American pharmaceutical company Teva Pharmaceutical’s Cinqaero (reslizumab), to treat adult patients with severe eosinophilic asthma.

By Lopamudra Roy

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending marketing authorisation for Israeli-American pharmaceutical company Teva Pharmaceutical’s Cinqaero (reslizumab), to treat adult patients with severe eosinophilic asthma.

Cinqaero (reslizumab) is a humanised, interleukin-five antagonist, monoclonal antibody used for add-on therapy in adult patients suffering from the disease, which is inadequately controlled in spite of high-dose inhaled corticosteroids, along with another medicinal product for maintenance treatment.

Teva Pharmaceutical global specialty medicines president and CEO Dr Rob Koremans said: "As a company committed to providing medicines and solutions for people around the world living with respiratory disease, Teva is very pleased to report a positive opinion by CHMP for the first intravenous, anti-IL-5 biologic therapy for severe eosinophilic asthma.

"In clinical trials, reslizumab was effective in reducing asthma exacerbations, improving lung function and improving asthma-related quality of life measures.

"Teva is very pleased to report a positive opinion by CHMP for the first intravenous, anti-IL-5 biologic therapy for severe eosinophilic asthma."

"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."

The positive opinion granted by CHMP is based on a review of a Marketing Authorisation Application (MAA) comprising efficacy and safety data from Teva Pharmaceutical’s global development programme in asthma.

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The most common adverse reaction that can occur while treating a severe eosinophilic asthma patient with reslizumab is increased blood creatinine phosphokinase.

The final decision on the approval of marketing authorisation of Cinqaero will be granted by the European Commission (EC) and is expected in the second half of this year.

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