The European Commission (EC) has granted marketing authorization for Teva Pharmaceutical’s Cinqaero (reslizumab) in all European Union (EU) nations, Norway, Liechtenstein, and Iceland. The therapy treats inadequately controlled asthma in adult and adolescent patients with elevated blood eosinophils, despite an inhaled corticosteroid-based regime.
Cinqaero is a biological therapy containing a monoclonal antibody called anti-interleukin-5 or IL-5, an important cytokine that plays a pivotal role in the development of eosinophils (a type of white blood cell) which are found to be elevated in many patients with asthma. High levels of eosinophils correspond to a more severe asthma and more exacerbations.
The drug works against asthma by binding and blocking the IL-5 receptor making it difficult for IL-5 to enhance the function of eosinophils in asthmatics. Cinqaero intravenously administered at a weight-based dose of 3 mg/kg, once every four weeks is approved for the treatment of asthma patients who have not experienced significant improvements after taking inhaled corticosteroids.
“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 Guy Brusselle, a professor from Ghent University Hospital, Belgium in a press release.
“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.
Burselle said that clinical trials for Cinqaero consistently demonstrated the ability to improve multiple levels of asthma control that included the reduction of exacerbations and improvement of lung function and quality of life.
The EC approval was based on safety and efficacy data from Teva’s BREATH asthma global development program. BREATH consisted of five placebo-controlled clinical trials that evaluated the efficacy and safety profile of the drug in 1,028 adult and adolescent patients with severe asthma who received treatment with Cinqaero (3 mg/kg) every four weeks. All patients had asthma that was inadequately controlled with inhaled corticosteroid-based therapies.
“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 Dr. Rob Koremans, president and chief executive officer 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.”
Teva expects Cinqaero to become commercially available to patients in Europe during the next few months. The therapy is currently available in the United States and Canada as Cinqair injection.