European Commission approves Cinqaero (reslizumab)as add-on therapy in adult patients with severe eosinophilic asthma. Teva

Teva Pharmaceutical Industries Ltd. announced that the European Commission has granted marketing authorization for Cinqaero (reslizumab) (Cinqair in the US) in the 28 countries of the European Union (EU) in addition to Norway, Liechtenstein and Iceland. Cinqaero is a humanized interleukin-5 antagonist monoclonal antibody 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.

The approval by the European Commission was based on review of efficacy and safety data from Teva�s global development program, BREATH, in asthma. The clinical trial program consisted of five placebo-controlled studies. The program explored the efficacy and safety profile in a population of 1,028 adult and adolescent severe asthma patients treated with Cinqaero 3 mg/kg every four weeks that were inadequately controlled with inhaled corticosteroid (ICS)-based therapies. Side effects included increased blood creatine phosphokinase, myalgia and anaphylactic reactions.

Comment: Reslizumab was FDA approved as Cinqair as add-on maintenance treatment of patients with severe asthma aged 18 years and older, and with an eosinophilic phenotype in March 2016. The drug is also approved in Canada.