ARTICLE | Clinical News

Xolair omalizumab regulatory update

October 6, 2014 7:00 AM UTC

FDA updated the label of Xolair omalizumab from Roche warning of a "slightly" increased risk of cardiovascular and cerebrovascular serious adverse events in patients receiving the asthma drug. FDA also updated the warnings and precautions section of the label to include potential cancer risk. Xolair is approved in the U.S. to treat moderate to severe asthma in adults and children age >12 years whose condition is not controlled by inhaled steroids and to treat chronic idiopathic urticaria.

The updated label includes data from a 5-year safety study evaluating 7,836 patients submitted by Roche's Genentech unit combined with a meta-analysis of 25 double-blind, placebo-controlled clinical trials evaluating Xolair. Due to study limitations, FDA was unable to determine the exact increase in risk of cardiovascular and cerebrovascular events associated with Xolair. FDA said its review of the 5-year safety study also found no difference in the rates of cancer between those patients treated with Xolair and those who were not treated with the drug, but due to limitations in study, the agency said it could not rule out a potential risk of cancer with Xolair ...