ARTICLE | Clinical News

Xolair omalizumab regulatory update

November 23, 2009 8:00 AM UTC

An FDA panel voted 10-4 that data for Xolair omalizumab from Genentech and Novartis do not support its approval to treat asthma in children ages 6-11 with moderate to severe persistent asthma whose symptoms are inadequately controlled with inhaled corticosteroids. The Pulmonary-Allergy Drugs Advisory Committee also voted 9-5 that the safety of Xolair has not been adequately assessed in the population. The panel was split 7-7 on whether Xolair provides a clinically meaningful beneficial effect for the indication. ...