The European Commission has issued a green light for Teva's Cinqaero in the 28 countries of the European Union in addition to Norway, Liechtenstein and Iceland.
The drug, a humanised interleukin-5 antagonist monoclonal antibody produced by recombinant DNA technology, can now be used as add-on therapy in adults with severe eosinophilic asthma inadequately controlled despite high-dose inhaled corticosteroids plus another medicinal product for maintenance treatment.
Approval came on the back of efficacy and safety data from Teva's global development programme, BREATH, in asthma, involving 1,028 adult and adolescent severe asthma patients treated with Cinqaero (reslizumab) every four weeks that were inadequately controlled with inhaled corticosteroid (ICS)-based therapies.
Two Phase III trials under the programme showed statistically significant reductions in the frequency of clinical asthma exacerbations compared to placebo of 50 percent and 60 percent.
"In clinical trials, reslizumab was effective in reducing asthma exacerbations, improving lung function and improving asthma-related quality of life measures," said Rob Koremans, president and chief executive of Teva Global Specialty Medicines, back in June. Side effects included increased blood creatine phosphokinase, myalgia and anaphylactic reactions.
"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."
Uncontrolled asthma impacts a large number of patients, presenting a major challenge for clinicians and a significant burden on healthcare systems. According to Teva, it is estimated that the market for severe asthma biotech drugs could exceed $7.5 billion a year in the US and Europe alone.
Cinqaero was approved by US regulators in March under the brand name Cinqair.