Reslizumab has been recommended for approval by an FDA advisory committee for use in treating adults 18 years and older with asthma.
The monoclonal antibody reslizumab was recommended for approval by the US Food and Drug Administration’s (FDA’s) Pulmonary and Allergy Drugs Advisory Committee yesterday for use in treating adults aged 18 years and older with moderate to severe asthma.
The committee said safety and efficacy data weren’t strong enough for it to recommend approval of the drug for children aged 12 to 17 years.
As to whether the safety and efficacy data support approval of the monoclonal antibody at a dose of 3 mg/kg by intravenous injection once every 4 weeks, the committee voted 11 to 3 in favor of treating adults and a resounding no (14 to 0) for children.
The meeting was called to discuss the biologics license application for reslizumab for injection, submitted by Teva Pharmaceutical Industries Ltd to reduce exacerbations, relieve symptoms, and improve lung function for people 12 years old and older with asthma and elevated blood eosinophils whose condition is inadequately controlled with inhaled corticosteroids.