Teva Announces European Medicines Agency (EMA) Confirms Successful Validation of Reslizumab Marketing Authorisation Application

CASTLEFORD, England, August 24, 2015 /PRNewswire/ --

Teva UK Limited acknowledges the successful filing by Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) of a Marketing Authorisation Application (MAA) with the European Medicines Agency (EMA) for reslizumab. Reslizumab is a humanised anti-interleukin-5 (IL-5) monoclonal antibody (mAb) for the treatment of inadequately controlled asthma in patients with elevated blood eosinophils, despite an inhaled corticosteroid (ICS)-based regimen.

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"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 MAA for reslizumab includes data from Teva's Phase III clinical trial programme. The results of two of these trials were published in The Lancet^[1] and showed that adult and adolescent asthma patients with elevated blood eosinophils, whose symptoms were inadequately controlled with inhaled corticosteroid-based therapies, experienced reduced asthma exacerbation rates and significantly improved lung function, quality of life and other secondary measures of asthma control with reslizumab as add-on therapy, versus placebo.

"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."