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Cardiovascular Events in Omalizumab Trial Prompt FDA Scrutiny
Posted by: admin in Pharmacy Drugs on August 22nd, 2009
WASHINGTON, July 16 — The FDA is reviewing safety data from an ongoing trial of the asthma drug omalizumab (Xolair) after interim results showed an excess of cardiovascular and cerebrovascular events among patients taking the drug.
The agency issued an early communication today about the review, which focuses on the Evaluating the Clinical Effectiveness and Long-Term Safety in Patients with Moderate to Severe Asthma (EXCELS) trial.
The observational study is following some 5,000 asthma patients taking omalizumab — a monoclonal antibody targeting IgE antibodies — and 2,500 other patients treated with different medications.
“The interim data, submitted by the manufacturer of Xolair (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 to the control group of patients not given the drug,” according to the FDA’s announcement.
It did not provide specific numbers of events or other details.
The agency said it was not recommending that patients stop taking Xolair, nor is it going to demand label changes at this point.
“FDA has not made any conclusions regarding these data,” the announcement said.
Nor has the trial been stopped.
“The agency is working with Genentech to obtain further information and will continue to review the strengths and limitations of these interim results,” the FDA statement said. “For example, since EXCELS is an observational study, there could be differences in underlying risk factors for cardiovascular and cerebrovascular events between the two study groups.”
The agency urged healthcare professionals and patients to report side effects associated with omalizumab to its MedWatch safety program.
Omalizumab is currently approved for use by individuals at least 12 years old 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.
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