Actimmune (Interferon Gamma-1B) - FDA Alerts

FDA Alerts related to Actimmune (Interferon Gamma-1B)

Interferon gamma-1b (marketed as Actimmune) Information

FDA ALERT [3/9/2007]: FDA is issuing this alert to advise you of the early termination of the INSPIRE clinical study of Actimmune for idiopathic pulmonary fibrosis (IPF). The study was stopped because an interim analysis showed that patients with IPF who received Actimmune did not benefit. The trial compared survival in patients getting Actimmune or an inactive injection (placebo). An analysis showed that 14.5% of patients treated with Actimmune died as compared to 12.7% of patients treated with placebo. Actimmune is not approved by the FDA to treat IPF.