Dear Colleagues,

On Wednesday, the Pulmonary-Allergy Drugs Advisory Committee of the FDA met to discuss a proposed indication for omalizumab (Xolair) which would expand its use to treat moderate to severe persistent asthma in children between 6 and 11 years of age whose symptoms are inadequately controlled with moderate to high doses of inhaled steroid medications and have (a) a positive reaction to skin testing with a perennial aeroallergen, or (b) in vitro reactivity, which is measured with a blood test that confirms the presence of specific IgE antibody consistent with allergies and asthma.

The panel voted (10-4) against recommending approval of omalizumab for this pediatric indication.

According to the panel, although the efficacy was recognized, it was not sufficient to warrant approval when considering the risk-benefit ratio. Concerns were raised about adverse events shown in adult populations, including cardiovascular side effects and the possibility of a link to cancer. However, these adverse events were not present in studies involving children.

The FDA will consider the panel's input as it decides whether to approve the expanded use of Xolair. The agency usually follows panel recommendations.

In light of this decision, the AAAAI and ACAAI recommend continuing the use of omalizumab, while always balancing the risk-benefit ratio.

Sincerely,

Paul A. Greenberger, MD, FAAAAI, FACAAI President, American Academy of Allergy, Asthma & Immunology	Sami L. Bahna, MD, DrPH, FACAAI, FAAAAI President, American College of Allergy, Asthma & Immunology

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