Xolair

Xolair is manufactured and marketed by Genentech as the first humanized antibody for the treatment of asthma, and the first FDA-approved therapy designed to target the antibody IgE, a key underlying cause of the symptoms of asthma caused by allergies. Xolair is delivered by injection.

In clinical studies of Xolair prior to FDA approval, patients experienced anaphylaxis, a serious allergic reaction that can be fatal, at a rate of about 1 in 1,000 patients, or approximately 0.1 percent of the patient population. However, since approval of the drug, the FDA has continued to receive reports of anaphylaxis in patients on Xolair, even in patients who had no reaction to their first dose. In some cases anaphylaxis was delayed for up to 24 hours after Xolair was injected, posing a serious threat of death for Xolair patients.

The FDA reminds patients taking Xolair to always carry and know how to administer emergency self-treatment for anaphylaxis, usually given in the form of an Epi-Pen injection.

On July 7, 2007, the U.S. FDA said the popular asthma drug Xolair will now carry a “black box” warning – the FDA’s most serious warning – because the drug may cause patients to have a severe allergic reaction.

Get more information from the FDA on Xolair.