The FDA on Wednesday announced the approval of Teva's Cinqair (reslizumab) for use in combination with other medicines for the maintenance treatment of severe asthma in patients aged 18 and older. The agency said the drug, a humanised interleukin-5 antagonist monoclonal antibody, is intended for use in patients with a history of severe asthma exacerbations despite treatment.
Badrul Chowdhury, director of the Division of Pulmonary, Allergy, and Rheumatology Products in the FDA's Center for Drug Evaluation and Research, remarked "health care providers and their patients with severe asthma now have another treatment option to consider when the disease is not well controlled by their current asthma therapies."
Teva noted that the FDA clearance, which marks the first approval of Cinqair anywhere in the world, was based on efficacy and safety data from five studies involving a total of 1028 adults and adolescents with severe asthma that was not controlled by inhaled corticosteroids. According to the drugmaker, three of these trials constituted the Phase III programme, showing that treatment with Cinqair was associated with a reduction of asthma exacerbations of up to 59 percent.
Teva said that upon US launch of the therapy, which is expected in the second quarter, it will introduce "a comprehensive programme that will provide personalised support, training and education to healthcare providers and patients who have been prescribed Cinqair." The drugmaker noted that the therapy is under review for marketing authorisation in Europe, while the drug has also been submitted for regulatory approval in Canada.
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