FDA Alert: Reslizumab for Eosinophilic Asthma
In December, a Food and Drug Administration (FDA) advisory committee voted in favor of approval of reslizumab for the treatment of eosinophilic asthma in patients over 18-years-old. According to MedPage Today, the FDA Pulmonary-Allergy Drugs Advisory Committee voted 11 to 3 for approval in adults, but voted unanimously against approval in children ages 12 to 17.
Reslizumab is an investigational humanized interleukin-5 (IL-5) antagonist IgG4K monoclonal antibody (mAb), for the treatment of uncontrolled asthma in patients with elevated blood eosinophils, despite the use of inhaled corticosteroids.
The FDA is not required to follow the advice of its advisory committees but it often does.