Teva Pharmaceutical has secured marketing authorisation for CINQAERO (reslizumab) from the European Commission.
This authorisation has been granted for 28 countries within the European Union (EU) in addition to Norway, Liechtenstein and Iceland.
INQAERO is a humanised, interleukin-5, antagonist monoclonal antibody for add-on therapy intended for adult patients suffering with severe eosinophilic asthma, which has been inadequately controlled despite high-dose inhaled corticosteroids in addition to another medicinal product for maintenance treatment.
Belgium's Ghent University Hospital professor Guy Brusselle said: “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 was granted based on review of efficacy and safety data from Teva’s global development programme, BREATH, in asthma.
This clinical trial programme comprised five placebo-controlled studies.
The programme explored the efficacy and safety profile in a population of 1,028 adult and adolescent severe asthma patients, who were administered with CINQAERO 3mg/kg every four weeks as they were not adequately controlled with inhaled corticosteroid (ICS)-based therapies.
The side effects during treatment included increased blood creatine phosphokinase, myalgia and anaphylactic reactions.
Teva global specialist medicines president and CEO said: “Severe asthma is a significant health issue in Europe and around the world, and finding an effective treatment option may be a challenge for patients living with a severe form of the condition marked by elevated eosinophils.
“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 will become commercially available in Europe over the next few months.
CINQAERO is currently approved and marketed within the US and Canada as CINQAIR (reslizumab) injection, and regulatory approvals are pending in other global markets.