The FDA is conducting a safety review of Xolair, a drug used to treat certain adults and adolescents with moderate to severe persistent asthma, due to possible cardiovascular problems and other adverse effects.
According to the agency, reviewers are looking for a possible association between patients who use Xolair and an increased risk of heart attack, abnormal heart rhythm, heart failure and stroke.
The potential adverse effects were identified from interim results from an ongoing study of Xolair -- Evaluating the Clinical Effectiveness and Long-Term Safety in Patients with Moderate to Severe Asthma (EXCELS). The study is being conducted by its San Francisco-based manufacturer, Genentech.
EXCELS is an observational study of approximately 5,000 Xolair treated patients and a control group of approximately 2,500 non-Xolair treated patients. The primary objective of the study is to assess the long-term safety profile of Xolair in patients followed for five years.
The interim data, submitted by Genentech, suggests a disproportionate increase in ischemic heart disease, arrhythmias, cardiomyopathy, cardiac failure, pulmonary hypertension, cerebrovascular disorders, and embolic, thrombotic and thrombophlebitic events in patients treated with Xolair, compared with the control group of patients not given the drug.
Xolair (omalizumab) is approved for use by adults and adolescents 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.