Dive Brief:
- InterMune, which is currently in the process of being acquired by Roche, presented long-term safety and tolerability data for its durable pirfenidone treatment Esbriet at the European Respiratory Society meeting in Munich.
- Analysis of 72-week progression-free survival (PFS) data showed a 38% reduction in the risk of progression, compared with placebo.
- The treatment showed benefit on several measures of idiopathic pulmonary fibrosis, including a reduced risk of mortality.
Dive Insight:
Esbriet is surpassing expectations, though it clearly showed plenty of promise at earlier stages of clinical development. In July, the FDA designated Esbriet as a breakthrough therapy, with the action date set for November 23. Overall, the 72-week Esbriet treatment data showed durable treatment-related benefits, as well as a favorable safety and tolerability profile. During clinical study of the effect of Esbriet in IPF patients, all-cause mortality was reduced by 37% and the risk of treatment-emergent IPF-related mortality was reduced by 60%.