EC Grants Marketing Authorization to Teva's Asthma Biologic

Teva announced that the European Commission has granted marketing authorization for CINQAERO (reslizumab) 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.

“For patients living with severe asthma, there is a significant unmet need when it comes to treatment options, despite today’s standard of care,” said Professor Guy Brusselle, Ghent University Hospital, Belgium. “It is exciting and encouraging to see the approval of CINQAERO® in Europe as physicians seek targeted treatment options for this specific subset of patients living with uncontrolled severe eosinophilic asthma. In clinical trials, CINQAERO® consistently demonstrated the ability to improve multiple levels of asthma control, including the reduction of exacerbations and improvement of lung function and quality of life, making it an important treatment option for those struggling to control their disease.”

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.

“Severe asthma is a significant health issue in Europe and around the world– and for patients living with a severe form of the condition marked by elevated eosinophils – finding an effective treatment option may be a challenge,” said Rob Koremans, MD, President and CEO of Teva Global Specialty Medicines. “The approval in Europe is a significant milestone for Teva, reinforcing the important work our respiratory division has done, and continues to do, in developing innovative therapies. It is our hope that the availability of this treatment may better serve, and bring much-needed relief, to patients with severe asthma who are still struggling with symptom control, despite standard of care therapy.”

CINQAERO is expected to become commercially available to patients in Europe, by prescription, within the coming months. CINQAERO® is currently approved and marketed in the United States and Canada as CINQAIR® (reslizumab) Injection with pending regulatory approvals in other global markets.