Dear Colleagues:

Late last week, the Federal Drug Administration (FDA) announced that Novartis and Genentech are subject to FDA's Risk Evaluation and Mitigation Strategy (REMS). As such they are required to assess, evaluate and report to the FDA at 9 months, 18 months, 3 years and 7 years the following six data points as they relate to Xolair (Omalizumab):

1. patients' understanding of the serious risks of Xolair as it pertains to anaphylaxis
2. an assessment of the distribution of the medication guide
3. failures to adhere to the distribution requirements of the medication guide and corrective actions taken to address noncompliance
4. data showing who is prescribing Xolair and why
5. analysis of cases of anaphylactic reactions and other factors resulting in serious outcomes
6. updates to any post-approval study or clinical trial required

These requirements are the responsibility of the sponsor. They will utilize a third party vendor to collect some of this data, although at this time we do not know the specific process and procedure that will be followed.

Many of the FDA's points involve data collection on the part of physicians. Additionally, we would like to call your attention to the third item, which stresses the importance of distributing the medication guide. While neither the companies nor the FDA can compel physicians to distribute the medication guide - data will be collected as to whether this is being done.

For more information regarding this REMS, visit:
http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders

For a copy of the medication guide visit:
http://www.fda.gov/downloads/Drugs/DrugSafety/ucm089829.pdf

Sincerely,

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American Academy of Allergy, Asthma & Immunology
555 East Wells Street, Suite 1100
Milwaukee, WI 53202-3823
Phone: (414) 272-6071
E-mail: info@aaaai.org.