The US Food and Drug Administration has agreed to review Teva’s biologic reslizumab as a potential treatment for eosinophilic asthma.
Teva is seeking approval for the humanised monoclonal antibody, which targets interleukin-5, as a treatment of inadequately controlled asthma in adult and adolescent patients with elevated levels of blood eosinophils despite therapy with an inhaled corticosteroid (ICS)-based regimen.
“Despite currently available medicines, uncontrolled asthma remains a serious problem for patients, physicians and healthcare systems, highlighting the need for targeted new treatment options,” noted Michael Hayden, president of global R&D and chief scientific officer at the Israeli drugmaker.
In clinical trials, reslizumab cut asthma exacerbation rates by at least half and provided significant improvement in lung function and other secondary measures of asthma control when added to an existing ICS-based therapy, the firm said.
Common adverse events were comparable to placebo and included worsening of asthma, nasopharyngitis, upper respiratory infections, sinusitis, influenza and headache.
The FDA is expected to reach its decision by March next year.
Analysts believe IL-5 products - including GlaxoSmithKline’s mepolizumab, which has just received unanimous backing for approval from FDA advisors for adults (but not adolescents) - could expand the asthma market by billions of dollars.