Teva Pharmaceutical Industries has announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending marketing authorization for CINQAERO® (reslizumab), 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.
“As a company committed to providing medicines and solutions for people around the world living with respiratory disease, Teva is very pleased to report a positive opinion by CHMP for the first intravenous anti-IL-5 biologic therapy for severe eosinophilic asthma,” said Rob Koremans, MD, President and CEO of Teva Global Specialty Medicines. “In clinical trials, reslizumab was effective in reducing asthma exacerbations, improving lung function and improving asthma-related quality of life measures. It is our hope that we can expand the availability of reslizumab globally and soon bring this important treatment option to a specific group of severe eosinophilic asthma patients in Europe who struggle to control their symptoms despite today’s standard of care.”
The CHMP opinion is based on review of a Marketing Authorization Application (MAA) containing efficacy and safety data from Teva’s global development program in asthma. The clinical trial program consisted of five placebo-controlled studies which demonstrated the efficacy and/or safety profile in a population of 1,028 adult and adolescent asthma patients treated with reslizumab 3 mg/kg that were inadequately controlled with inhaled corticosteroid (ICS)-based therapies. Three of these studies constituted the Phase III program in patients with asthma and elevated blood eosinophils greater than 400 cells/mcL, where reslizumab was administered for up to 52 weeks. They demonstrated that treatment with reslizumab reduced the annual rate of asthma exacerbations in the two 52-week trials by 50 and 59 percent, respectively. In addition, reslizumab was associated with significant improvement in lung function, patient-reported asthma control and asthma-related quality of life measures. The most commonly reported adverse reaction during treatment was increased blood creatinine phosphokinase, which occurred in approximately two percent of patients. These were mostly mild, transient, asymptomatic and did not lead to treatment discontinuation. Adverse reactions of myalgia and anaphylactic reaction were uncommon and occurred in less than one percent of patients.
The CHMP positive opinion is a formal recommendation to grant marketing authorization for reslizumab. The recommendation will now be reviewed by the European Commission, which has authority to approve medicines for use in the 28 countries of the European Union along with Norway, Liechtenstein and Iceland. The final decision by the European Commission is expected in the second half of 2016.