EMA confirms successful validation of Teva’s reslizumab MAA

Reslizumab is designed to treat inadequately controlled asthma in adult patients with elevated blood eosinophils, despite an inhaled corticosteroid (ICS)-based regimen.

The MAA is based on data from the company’s Phase III BREATH clinical trial program, which included four separate placebo-controlled Phase III trials specifically designed to include a targeted population of 1,700 adult and adolescent asthma patients.

These trials evaluated asthma patients with elevated blood eosinophils, whose symptoms were inadequately controlled with inhaled corticosteroid-based therapies.

Teva Pharmaceutical Industries Global R&D president and chief scientific officer Dr Michael Hayden said: "Uncontrolled asthma remains a serious challenge for patients and healthcare professionals despite the availability of standard of care treatment.

"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."

Results from these trials showed that reslizumab, compared to placebo, reduced asthma exacerbation rates by at least half and provided significant improvement in lung function, quality of life and other secondary measures of asthma control as add-on therapy.

The EMA is expected to take a final decision on reslizumab in the second half of next year.

In June, the US Food and Drug Administration (FDA) had accepted a Biologics License Application (BLA) for reslizumab, with FDA Regulatory Action expected in March 2016.