Actimmune Trial for Pulmonary Fibrosis Halted Early
The drug did not improve survival compared to placebo
TUESDAY, March 13 (HealthDay News) -- InterMune of Brisbane, Calif., has announced the early termination of a clinical trial for its drug Actimmune as a treatment for idiopathic pulmonary fibrosis, according to the U.S. Food and Drug Administration. Interim findings from the INSPIRE trial showed that the drug did not improve survival; 14.5 percent of patients in the treatment group died, versus 12.7 percent in the placebo group.
The drug, which is a synthetic version of interferon gamma-1b, is currently FDA-approved for patients with severe, malignant osteopetrosis and chronic granulomatous disease.
The FDA recommends that physicians discuss the results of the trial with their patients currently taking Actimmune for idiopathic pulmonary fibrosis, and decide whether or not they should continue. There are no other drugs that are effective in treating the condition.
"FDA intends to evaluate the INSPIRE study results and, if the review reveals additional important information to share, will notify health care providers and patients," according to an FDA statement.