Teva Gets CHMP Positive Opinion For CINQAERO - Quick Facts

(RTTNews) - Teva Pharmaceutical Industries Ltd. (TEVA) said Friday that the Committee for Medicinal Products for Human Use, or CHMP, of the European Medicines Agency, or EMA, has issued a positive opinion, recommending marketing authorization for CINQAERO, a humanized interleukin-5 (IL-5) antagonist monoclonal antibody.

The CHMP positive opinion is for the antibody CINQAERO for add-on therapy in adult patients with severe eosinophilic asthma inadequately controlled despite high-dose inhaled corticosteroids plus another medicinal product for maintenance treatment and the opinion is based on review of a Marketing Authorization Application containing efficacy and safety data from Teva's global development program in asthma.

The CHMP positive opinion is a formal recommendation to grant marketing authorization for reslizumab. The recommendation will now be reviewed by the European Commission, and the final decision will be announced in the second half of 2016.