The FDA is looking into a potential link between Roche and Novartis’ Xolair (omalizumab) and an elevated risk of cardiovascular and cerebrovascular adverse events, according to an early communication notice issued by the regulator on Thursday. The agency, which is evaluating interim safety findings from an ongoing study of the asthma drug, indicated that it is not recommending changes to the drug’s label at this time.

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The observational EXCELS study involves approximately 5000 patients treated with Xolair, and a control group of roughly 2500 patients not treated with the product. Patients are 12 years of age and older with moderate-to-severe persistent asthma who tested positive for an aeroallergen. The FDA explained that the study, submitted to the agency by Roche’s Genentech unit, was designed to assess the long-term safety profile of Xolair during 5 years of follow-up.

According to the regulator, the interim data suggest “a disproportionate increase in ischemic heart disease, arrhythmias, cardiomyopathy and cardiac failure, pulmonary hypertension, cerebrovascular disorders, and embolic, thrombotic and thrombophlebitic events” in the Xolair arm, compared to the control group.

The FDA is working with Genentech to obtain further information and will pursue its review of the data. Final results from the EXCELS study are expected in 2012. Genentech spokesperson Tara Cooper said Genentech and Novartis will continue gathering safety information about the drug, but that “at this time, there is insufficient information for the companies to change their assessment of the benefit-risk profile for Xolair.” The treatment generated sales of $517 million for Genentech last year.

Source: FirstWord

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