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FDA Date: 3/8/07
Actimmune (interferon gamma-1b) FDA Drug Safety Communication
Information for Healthcare Professionals: Interferon gamma-1b (marketed as Actimmune)
FDA is issuing this alert to advise healthcare professionals 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.
This information reflects the current analysis of data available to FDA concerning this drug. FDA intends to update this communication when additional information or analyses become available.