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Pharmaceuticals / Regulatory Affairs / Postmarket Safety

FDA Requiring Cardiac and Cerebral Warnings on Genentech’s Xolair Label

Oct. 2, 2014

The FDA is requiring new cardiac and cerebral warnings for Genentech’s asthma drug Xolair, based on an evaluation of long-term safety data, but the agency stopped short of mandating the strictest black box warning.

The agency’s action is the latest for Xolair (omalizumab), which won approval in 2003 for patients 12 years and older with moderate to severe persistent asthma that is uncontrolled with inhaled corticosteroids and whose blood or skin test positive to year-round allergens in the air.
In 2009, the FDA issued a safety alert suggesting that Xolair was associated with increases in cardiovascular incidents.

A subsequent review of roughly 30 clinical trials, including a five-year observational study, concluded that patients treated with the drug had slightly higher rates of transient ischemic attacks, heart attacks, sudden chest pain, pulmonary hypertension and blood clots.

The agency is requiring this information be added to the “Adverse Reactions” section of the drug’s labeling rather than calling for a black box warning. This decision was based on factors such as patients’ youth, which make the true prevalence of adverse events difficult to determine, the agency says.

Genentech spokeswoman Austine Graff pointed out that no indications were changed and no restrictions were placed on the drug. The company worked closely with the FDA on the updated labeling, she said. — Lena Freund

Originally appeared in Drug Industry Daily, the pharmaceutical industry’s number one source for regulatory news and information. Click here for more information.