FDA continues to evaluate Xolair study findings

The US FDA is evaluating interim safety findings from an ongoing study of Xolair (omalizumab) that suggests patients using the drug suffer an increased number of cardiovascular and cerebrovascular adverse events compared with a control group who are not taking it.

Xolair is approved for use by adults and adolescents (12 years of age and above) with moderate to severe persistent asthma who test positive for reactivity to a perennial airborne allergen, and whose symptoms are inadequately controlled with inhaled corticosteroids.

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 Xolair-treated patients and a control group of around 2,500 patients. The primary objective of the EXCELS study is to assess the long-term safety profile of Xolair in patients followed for five years. Study patients are 12 years of age and older with moderate to severe persistent asthma who have a positive skin or blood test for an aeroallergen.

The interim data, submitted by the Xolair's manufacturer Genentech, suggests a disproportionate increase in ischemic heart disease, arrhythmias, cardiomyopathy and cardiac failure, pulmonary hypertension, cerebrovascular disorders, and embolic, thrombotic and thrombophlebitic events in patients treated with Xolair compared with the control group.

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

The Agency has not made any conclusions regarding the data. The Agency is working with Genentech to obtain further information and will continue to review these interim results. Final results of the EXCELS study are not expected until 2012.

The FDA urges healthcare professionals and patients to report side effects from the use of omalizumab to its MedWatch Adverse Event Reporting programme.