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FDA Public Health Advisory: Interferon Gamma 1-b (marketed as Actimmune)

FDA Public Health Advisory
Interferon gamma-1b (marketed as Actimmune)

On March 5, 2007, InterMune, the maker of Actimmune, reported the early stopping of the INSPIRE study of Actimmune for treating 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.

Actimmune is a synthetic version of interferon gamma-1b, a naturally occurring biologic response modifier. FDA has approved Actimmune to decrease the number and severity of infections in patients with chronic granulomatous disease and to delay the progression of severe, malignant osteopetrosis.

IPF is a chronic progressive lung disease of unknown cause in which the lungs are scarred. IPF patients can have severe and disabling shortness of breath. The disease usually progresses and patients frequently die from respiratory failure. There are no drugs proven to be effective for treating IPF.

FDA makes the following recommendations:

Patients on Actimmune for IPF should discuss with their doctors whether they should continue to receive Actimmune treatment.
Doctors should discuss the results of this trial with their patients receiving Actimmune for IPF.
Doctors should carefully consider whether patients receiving Actimmune for IPF should continue to receive treatment with Actimmune.

FDA intends to evaluate the INSPIRE study results and, if the review reveals additional important information to share, will notify healthcare providers and patients.

The FDA urges both healthcare providers and patients to report side effects from medical products to MedWatch. MedWatch reports may be made by phone: 1-800-FDA-1088; fax: 1-800-FDA-0178; or via the Internet at http://www.fda.gov/medwatch/index.html.

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