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

lung transplantation, so we hope that this new longer-term safety data will reinforce the known safety and importance of Esbriet as the future standard of care for patients living with IPF," said Giacomo Di Nepi, InterMune's Senior Vice President and Managing Director, Europe.  "Germany is the first country in Europe where Esbriet is now available to patients, and we are glad to be able to offer now this new treatment opportunity to patients with mild to moderate IPF."

RECAP Study Results

At Week 72 in RECAP, mean exposure to pirfenidone 2403 mg/d across both studies was 2.9 years (range, 1-4); 114 patients had received Esbriet 2403 mg/d for at least three years.  The favorable safety and tolerability profile observed in CAPACITY and other prior clinical trials was confirmed in RECAP.

In RECAP, treatment-emergent adverse events (TEAE) and common adverse events (AEs) were very similar to those reported in CAPACITY:

  • 98 percent of RECAP patients reported at least one TEAE compared to 99 percent in the treatment arm and 98 percent in the placebo arm of the CAPACITY program.
  • In RECAP, 33 percent of patients had a serious TEAE compared to 33 percent in the treatment arm and 31 percent in the placebo arm during CAPACITY.
  • The incidence of common AEs in RECAP was very similar to that observed in CAPACITY and these AEs were generally mild to moderate in severity.  The type and frequency of adverse events were generally consistent with observations from the Phase 3 clinical trials; no new safety signals or trends were observed.
  • The overall incidence of photosensitivity or rash was lower in RECAP than in CAPACITY (20 percent of patients vs. 44 percent). Rash and photosensitivity reactions were more common among patients newly initiating treatment with pirfenidone compared with those who were continuing treatment (28 percent vs. 12 percent); however, the incidence w
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SOURCE InterMune, Inc.
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