Teva Announces EMA Validation of Reslizumab Marketing Authorization Application

Teva Announces EMA Validation of Reslizumab Marketing Authorization Application

eva UK Limited, one of the UK’s top ten pharmaceutical manufacturers, recently announced the successful filing of a Marketing Authorisation Application (MAA) with the European Medicines Agency (EMA) for its investigational drug reslizumab.

Reslizumab is a humanized monoclonal antibody (mAb) that is able to target interleukin-5 (IL-5). The therapy is being developed as a treatment for inadequately controlled asthma in adults and young people who have increased blood eosinophils, despite being under treatment with an inhaled corticosteroid (ICS) drug regimen.

“Uncontrolled asthma remains a serious challenge for patients and healthcare professionals despite the availability of standard of care treatment,” said Dr. Ewan Walters, Medical Director, Teva UK Limited. “There is a tremendous need for targeted new medicines. Clinical trials have shown that reslizumab significantly reduced the rate of asthma exacerbations and improved lung function in a specific group of patients with elevated eosinophil levels. This group of patients’ asthma was poorly controlled despite being on a standard treatment regimen. The successful filing of the MAA for reslizumab means that this patient population, which often experiences the most severe symptoms, is now one step closer to a new targeted treatment option in Europe.”

The Marketing Authorisation Application for the drug includes the results from the company Phase III clinical trial program.

Data regarding two of these clinical trials were recently published in the journal The Lancet and revealed that compared to placebo, patients with elevated levels of blood eosinophils who received treatment with the drug and that did not respond adequately to treatment with inhaled corticosteroids had a reduction in their rates of asthma exacerbation and also experienced an improvement in their quality of life, lung function, and other asthma control parameters.

“Through the development of novel molecules and inhaler devices, Teva is committed to delivering innovations in asthma care that help patients achieve improved asthma outcomes and quality of life,” said Robyn Hughes, Brands Director at Teva UK Limited. “We are delighted with this successful filing for reslizumab, which, if approved, will broaden and strengthen our respiratory offering and provide a much-needed new treatment for an underserved patient group.”

A final decision from the EMA on reslizumab is anticipated in the second half of 2016.

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