Creating a pathway in IPF

FDA generally dislikes pooled analyses of data - especially if the endpoint wasn't the primary endpoint and especially if one of the two trials being combined missed the primary endpoint. But InterMune Inc. last week convinced an advisory panel that pooled data from two Phase III trials of its Esbriet pirfenidone showed a survival benefit in patients with idiopathic pulmonary fibrosis, a progressive, fatal disease.

IPF is a complex, Orphan disease for which no regulatory pathway exists. For its Phase III program, InterMune chose a primary endpoint of change in forced vital capacity (FVC), which the company believed would be appropriate to show a clinical benefit in a condition characterized by progressive deterioration in lung function. The trial did not have an SPA...