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news.InterMune has discontinued the phase III clinical trial evaluating Actimmune in patients with idiopathic pulmonary fibrosis because of lack of benefit in survival for these patients.
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Although an independent data monitoring committee found that among the 826 patients, there was not a statistically significant difference between treatment groups in overall mortality.
The phase III study was designed to evaluate the safety and efficacy of Actimmune in idiopathic pulmonary fibrosis (IPF) patients with mild to moderate impairment in lung function. The primary endpoint was survival time.
“Although we are disappointed by this result with Actimmune, we remain committed to addressing the significant unmet medical need in IPF with pirfenidone through our phase III CAPACITY program,” said Dan Welch, president and CEO of InterMune
“We will promptly evaluate the implications of the study termination on our corporate strategy and our infrastructure. We expect to provide an update on this evaluation, including revised financial guidance, in the near future,” continued Dan Welch.
InterMune markets Actimmune for the treatment of life-threatening congenital diseases including chronic granulomatous disease and severe, malignant osteoporosis.