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FDA: Ongoing Omalizumab Study Shows Increased Number of Cardiovascular Events

ROCKVILLE, Md -- July 16, 2009 -- The US Food and Drug Administration (FDA) is evaluating interim safety findings from an ongoing study of omalizumab (Xolair) that suggests an increased number of cardiovascular and cerebrovascular adverse events in a group of patients using omalizumab compared with the control group.

The ongoing study, Evaluating the Clinical Effectiveness and Long-Term Safety in Patients with Moderate to Severe Asthma (EXCELS), is an observational study of approximately 5,000 patients receiving omalizumab and a control group of approximately 2,500 patients not receiving the drug.

The primary objective of the EXCELS study is to assess the long-term safety profile of omalizumab in patients followed for 5 years. Study patients are aged 12 years and older with moderate to severe persistent asthma and who have a positive skin test or blood test for an aeroallergen.

The interim data, submitted by the manufacturer of the drug (Genentech), suggests a disproportionate increase in ischaemic heart disease, arrhythmias, cardiomyopathy and cardiac failure, pulmonary hypertension, cerebrovascular disorders, and embolic, thrombotic and thrombophlebitic events in patients treated with omalizumab compared with the control group of patients not given the drug.

The FDA is not recommending any changes to the prescribing information for omalizumab and is not advising patients to stop taking omalizumab at this time.

Until the evaluation of the EXCELS study is completed, healthcare providers and patients should be aware of the risks and benefits described in the prescribing information, as well as the new information from the ongoing EXCELS study that may suggest a risk of cardiovascular and cerebrovascular adverse events.

The FDA has not made any conclusions regarding these data. The Agency is working with Genentech to obtain further information and will continue to review the strengths and limitations of these interim results. The Agency will communicate any new findings when its analysis of the interim safety data is complete. The EXCELS study is ongoing and final results are not expected until 2012.

The FDA urges both healthcare professionals and patients to report side effects from the use of omalizumab to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax, using the contact information at the bottom of this page.

- Contact Us 1-800-332-1088
1-800-FDA-0178 Fax
MedWatch Online
Regular Mail: Use postage-paid FDA Form 3500
Mail to: MedWatch 5600 Fishers Lane
Rockville, MD 20852-9787

SOURCE: US Food and Drug Administration

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