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Teva receives EU approval for new biologic asthma therapy
Teva has been granted European regulatory approval for Cinqaero, a humanised interleukin-5 antagonist monoclonal antibody for the treatment of asthma.
The European Commission has approved the intravenous anti-IL-5 biologic therapy for the treatment of severe eosinophilic asthma, making it the first drug of its kind to be approved in Europe for this indication.
It is intended for patients whose condition has proven to be inadequately controlled despite using high-dose inhaled corticosteroids plus another medicinal product for maintenance treatment, and has proven its safety and efficacy in clinical trials.
The global development programme BREATH evaluated the effectiveness of Cinqaero among 1,028 adult and adolescent severe asthma patients across a total of five placebo-controlled studies.
Dr Rob Koremans, president and chief executive officer of Teva Global Specialty Medicines, said: "The approval in Europe is a significant milestone for Teva, reinforcing the important work our respiratory division has done, and continues to do, in developing innovative therapies."
The drug will become commercially available to patients across Europe over the next few months. This follows its successful introduction in the US and Canada.
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