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New Data Demonstrate Longer-Term Safety Profile of Esbriet®
Date:9/26/2011

as similar to that observed among pirfenidone-treated patients in the CAPACITY studies.

About CAPACITY

The CAPACITY program was comprised of two multinational, double-blind, placebo-controlled Phase 3 studies (Study 004 and Study 006) that were conducted simultaneously with 779 IPF patients (aged 40-80 years) across 110 centers in Australia, Europe and North America. Patients were randomly assigned to receive oral Esbriet (1197 or 2403 mg/day) or placebo for a minimum of 72 weeks to evaluate the impact of Esbriet in reducing lung function deterioration in IPF patients.

CAPACITY results demonstrated that treatment with Esbriet:

  • Positively impacted key measures of lung function in IPF patients, including a significant reduction in the decline of Forced Vital Capacity (FVC).
  • Led to a significant reduction in the decline of Six-Minute Walk Test (6MWT) distance, an indication of improved pulmonary function.
  • In addition, an independent meta-analysis of progression free survival suggested a 30 percent lower risk of death or disease progression.(2)

About Esbriet

Esbriet (pirfenidone) is an orally active drug that inhibits the synthesis of TGF-beta, a chemical mediator that controls many cell functions including proliferation and differentiation, and plays a key role in fibrosis. It also inhibits the synthesis of TNF-alpha, a cytokine that is known to have an active role in inflammation.

On February 28, 2011, the European Commission (EC) granted marketing authorization for Esbriet in adults for the treatment of mild to moderate IPF. The approval authorizes marketing of Esbriet in all 27 EU member states. Esbriet has since been approved for marketing in Norway and Iceland. It is now available in Germany and is scheduled to be available in France, Italy and Spain during the first half of 2012 and in the United Kingdom duri
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SOURCE InterMune, Inc.
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