Teva Files MAA With European Medicines Agency For Reslizumab - Quick Facts

(RTTNews) - Teva Pharmaceutical Industries Ltd., (TEVA) said it has successfully filed a Marketing Authorization Application or MAA with the European Medicines Agency for reslizumab.

Reslizumab is a humanized anti-interleukin-5 monoclonal antibody for the treatment of inadequately controlled asthma in adult patients with elevated blood eosinophils, despite an inhaled corticosteroid-based regimen.

The MAA includes data from Teva's Phase III BREATH clinical trial program, which consisted of four separate placebo-controlled Phase III trials specifically designed to include a targeted population of 1,700 adult and adolescent asthma patients with elevated blood eosinophils, whose symptoms were inadequately controlled with inhaled corticosteroid-based therapies.

A final decision from the EMA on reslizumab is expected in the second half of 2016. A Biologics License Application for reslizumab was also accepted by the U.S. Food and Drug Administration in June, with regulatory action expected in March 2016.