Teva Pharmaceuticals’ biologic Cinqair has been cleared by the US Food and Drug Administration for the maintenance treatment of severe asthma in patients aged 18 years and older.
Cinqair (reslizumab) has been approved for use in combination with other other asthma medications in patients who have a history of severe asthma attacks (exacerbations) despite therapy.
The drug, a humanised interleukin-5 antagonist monoclonal antibody produced by recombinant DNA technology, is administered once every four weeks via intravenous infusion by a healthcare professional in a clinical setting prepared to manage anaphylaxis, because of the potential for life-threatening reactions in patients.
FDA approval came on the back of data showing that, compared with placebo, patients with severe asthma receiving Cinqair had fewer asthma attacks, and a longer time to the first attack, as well as a significant improvement in lung function.
“Despite currently available medicines, uncontrolled asthma remains a serious problem for patients, physicians and healthcare systems, highlighting the need for targeted new treatment options,” said Michael Hayden, president of global R&D and chief scientific officer at the Israeli drugmaker.
According to the Centers for Disease Control and Prevention, as of 2013, more than 22 million people in the US have asthma, and there are more than 400,000 asthma-related hospitalisations each year.
Analysts believe IL-5 products - including GlaxoSmithKline’s mepolizumab - could expand the asthma market by billions of dollars.