Omalizumab

[Tasha]

July 16, 2009 — Results of an interim safety analysis of a clinical trial evaluating omalizumab (Xolair, Genentech/Novartis) in patients with moderate to severe asthma suggest that use of the drug may be associated with a disproportionate increase in the incidence of certain cardiovascular adverse events compared with control subjects, the US Food and Drug Administration (FDA) announced today.

The interim safety findings were from the ongoing Evaluating the Clinical Effectiveness and Long-Term Safety in Patients with Moderate to Severe Asthma (EXCELS) trial, indicating increases in the incidence of ischemic heart disease, arrhythmias, cardiomyopathy and cardiac failure, pulmonary hypertension, cerebrovascular disorders, and embolic, thrombotic, and thrombophlebitic events in patients treated with omalizumab compared with control subjects, FDA announced.

The FDA is not recommending changes to safety labeling for for Xolair, and clinicians do not need to take their patients off the drug.

[Phat Skidz]

Interesant. Mulţumim.